INDY OTW VASCULAR RETRIEVER

Description of Event or Problem

COOK WAS NOTIFIED THAT THE GUIDE WIRE AND PROXIMAL PORTION OF THE CATHETER OF A COOK INDY OTW VASCULAR RETRIEVER SEPARATED. THE PATIENT WAS SCHEDULE TO UNDERGO AN EXCISIONAL ATHERECTOMY USING A COMPETITOR'S DEVICE. RIGHT RETROGRADE COMMON FEMORAL ARTERY (CFA) ACCESS WAS ACHIEVED WITH A 21 GAUGE NEEDLE USING ULTRASOUND GUIDANCE. AN 8 FRENCH SHEATH WAS PLACED. A GUIDE WIRE WAS ADVANCED THROUGH THE LUMENS OF THE VESSELS TO THE AORTA. AN ANGIOGRAM CONFIRMED FULL LENGTH ILIAC STENT OCCLUSION WITH RECONSTITUTION JUST ABOVE THE INGUINAL LIGAMENT. AN ATHEROTHROMBECTOMY USING A COMPEITOR'S DEVICE WAS PLANNED. THE COMPETITOR'S DEVICE REPRESENTATIVE WAS PRESENT FOR THE PROCEDURE. THE WIRE GUIDE WAS EXCHANGED FOR 0.018 COMPETITOR'S GUIDEWIRE. ON EARLY DEPLOYMENT OF THE ATHEROTHROMBECTOMY DEVICE, THE GUIDEWIRE SNAPPED WITHIN THE PROXIMAL EXTERNAL ILIAC ARTERY (EIA). THE PROXIMAL END OF THE GUIDE WIRE WAS IN THE ASCENDING AORTA. THE DISTAL END OF THE WIRE GUIDE WAS PROTRUDING THROUGH THE ILIAC STENT FENESTRATION INTO THE AORTIC WALL. ATTEMPTS TO SNARE FROM THE RIGHT GROIN WERE UNSUCCESSFUL. THE EVENT WAS DISCUSSED WITH THE VASCULAR SURGICAL ON-CALL TEAM. IT WAS DETERMINED TO ATTEMPT SNARING THE GUIDE WIRE FROM THE LEFT GROIN. LEFT RETROGRADE COMMON FEMORAL ARTERY (CFA) ACCESS WAS MADE USING A 21GAUGE NEEDLE USING ULTRASOUND GUIDANCE. AN 8FR SHEATH WAS INSERTED. THE COOK INDY OTW VASCULAR RETRIEVER WAS USED TO SNARE RETAINED THE INFRA-RENAL SEGMENT OF THE AORTIC WIRE. ON RETRIEVAL OF THE SNARE AND WIRE, THE INDY OTW VASCULAR RETRIEVER SNARE AND ITS PROXIMAL CATHETER SNAPPED LEAVING THE COMPETITOR'S GUIDE WIRE PROLAPSED INTO THE LEFT ILIAC ARTERY. THE INDY OTW VASCULAR RETRIEVER SNARE AND CATHETER FRAGMENT WAS RETAINED IN THE LEFT ILIAC ARTERY. NO FURTHER RETRIEVAL OPTIONS WERE AVAILABLE. THE TEAM ELECTED TO "JAIL "RETAINED SNARE/WIRE WITH COVERED STENT GRAFTS. BILATERAL KISSING STENTS (COMPETITOR'S BALLOON EXPANDABLE COVERED 7MM X 57MM STENTS) WERE PLACED. THE RIGHT SIDE WAS EXTENDED WITH COMPETITOR'S EXPANDABLE COVERED 7MM X 57MM STENTS) OVERLAPPING. THE LEFT SIDE WAS EXTENDED WITH OVERLAPPING COMPETITOR'S BALLOON EXPANDABLE COVERED 7MM X 50 MM STENTS. THE RETAINED WIRE AND SNARE WERE SUCCESSFULLY "JAILED" WITH PATENT ILIAC VESSELS ON COMPLETION ANGIOGRAM. POOR OUTFLOW ON THE RIGHT WITH SLUGGISH ANTEGRADE FLOW WAS IDENTIFIED. IT WAS KNOWN THAT THE PROXIMAL SUPERIOR FEMORAL ARTERY (SFA) AND PROFUNDA ORIGIN WERE STENOSED. THE RETROGRADE ANGIOGRAM SHOWED PATENT RIGHT ILIAC STENTS THE PROXIMAL END OF THE COMPETITOR'S WIRE GUIDE WAS LEFT FREE-FLOATING IN THE ASCENDING AORTA. THE SUBJECT OF THIS REPORT IS THE SEPARATED SNARE AND PROXIMAL CATHETER PORTION OF THE COOK INDY OTW VASCULAR RETRIEVER. COOK WAS NOTIFIED OF THE EVENT VIA A NOTIFICATION FROM MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (MHRA). MHRA DOES NOT HAVE PERMISSION TO PROVIDE THE CUSTOMER CONTACT INFORMATION. THEREFORE, NO ADDITIONAL INFORMATION CAN BE PROVIDED.

Additional Manufacturer Narrative

BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. D4 MODEL NUMBER: G51835 OR G51836. D4 CATALOG NUMBER: INDY-8.0-35-55-40 OR INDY-8.0-35-100-40. H3 - DEVICE EVALUATED BY MFG?: DEVICE NOT RETURNED TO MANUFACTURER. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED OR THAT A DEATH OR SERIOUS INJURY OCCURRED; NOR IS IT ADMISSION THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

Description of Event or Problem

NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

Additional Manufacturer Narrative

E1: COMPLAINT WAS SUBMITTED TO COOK BY (B)(6). CORRECTION, E1, H6 (ANNEX A), INVESTIGATION ¿ EVALUATION COOK WAS NOTIFIED THAT THE GUIDE WIRE AND PROXIMAL PORTION OF THE CATHETER OF A COOK INDY OTW VASCULAR RETRIEVER SEPARATED. THE PATIENT WAS SCHEDULED TO UNDERGO AN EXCISIONAL ATHERECTOMY USING A COMPETITOR'S DEVICE. RIGHT RETROGRADE COMMON FEMORAL ARTERY (CFA) ACCESS WAS ACHIEVED WITH A 21-GAUGE NEEDLE USING ULTRASOUND GUIDANCE. AN 8 FRENCH SHEATH WAS PLACED. A GUIDE WIRE WAS ADVANCED THROUGH THE LUMENS OF THE VESSELS TO THE AORTA. AN ANGIOGRAM CONFIRMED FULL LENGTH ILIAC STENT OCCLUSION WITH RECONSTITUTION JUST ABOVE THE INGUINAL LIGAMENT. AN ATHEROTHROMBECTOMY USING A COMPETITOR¿S DEVICE WAS PLANNED. THE COMPETITOR'S DEVICE REPRESENTATIVE WAS PRESENT FOR THE PROCEDURE. THE WIRE GUIDE WAS EXCHANGED FOR 0.018 COMPETITOR'S GUIDEWIRE. ON EARLY DEPLOYMENT OF THE ATHEROTHROMBECTOMY DEVICE, THE GUIDEWIRE SNAPPED WITHIN THE PROXIMAL EXTERNAL ILIAC ARTERY (EIA). THE PROXIMAL END OF THE GUIDE WIRE WAS IN THE ASCENDING AORTA. THE DISTAL END OF THE WIRE GUIDE WAS PROTRUDING THROUGH THE ILIAC STENT FENESTRATION INTO THE AORTIC WALL. ATTEMPTS TO SNARE FROM THE RIGHT GROIN WERE UNSUCCESSFUL. THE EVENT WAS DISCUSSED WITH THE VASCULAR SURGICAL ON-CALL TEAM. IT WAS DETERMINED TO ATTEMPT SNARING THE GUIDE WIRE FROM THE LEFT GROIN. LEFT RETROGRADE COMMON FEMORAL ARTERY (CFA) ACCESS WAS MADE USING A 21GAUGE NEEDLE USING ULTRASOUND GUIDANCE. AN 8FR SHEATH WAS INSERTED. THE COOK INDY OTW VASCULAR RETRIEVER WAS USED TO SNARE RETAINED THE INFRA-RENAL SEGMENT OF THE AORTIC WIRE. ON RETRIEVAL OF THE SNARE AND WIRE, THE INDY OTW VASCULAR RETRIEVER SNARE AND ITS PROXIMAL CATHETER SNAPPED LEAVING THE COMPETITOR'S GUIDE WIRE PROLAPSED INTO THE LEFT ILIAC ARTERY. THE INDY OTW VASCULAR RETRIEVER SNARE AND CATHETER FRAGMENT WAS RETAINED IN THE LEFT ILIAC ARTERY. NO FURTHER RETRIEVAL OPTIONS WERE AVAILABLE. THE TEAM ELECTED TO "JAIL "RETAINED SNARE/WIRE WITH COVERED STENT GRAFTS. BILATERAL KISSING STENTS (COMPETITOR'S BALLOON EXPANDABLE COVERED 7MM X 57MM STENTS) WERE PLACED. THE RIGHT SIDE WAS EXTENDED WITH COMPETITOR'S EXPANDABLE COVERED 7MM X 57MM STENTS) OVERLAPPING. THE LEFT SIDE WAS EXTENDED WITH OVERLAPPING COMPETITOR'S BALLOON EXPANDABLE COVERED 7MM X 50 MM STENTS. THE RETAINED WIRE AND SNARE WERE SUCCESSFULLY "JAILED" WITH PATENT ILIAC VESSELS ON COMPLETION ANGIOGRAM. POOR OUTFLOW ON THE RIGHT WITH SLUGGISH ANTEGRADE FLOW WAS IDENTIFIED. IT WAS KNOWN THAT THE PROXIMAL SUPERIOR FEMORAL ARTERY (SFA) AND PROFUNDA ORIGIN WERE STENOSED. THE RETROGRADE ANGIOGRAM SHOWED PATENT RIGHT ILIAC STENTS THE PROXIMAL END OF THE COMPETITOR'S WIRE GUIDE WAS LEFT FREE-FLOATING IN THE ASCENDING AORTA. THE SUBJECT OF THIS REPORT IS THE SEPARATED SNARE AND PROXIMAL CATHETER PORTION OF THE COOK INDY OTW VASCULAR RETRIEVER. COOK WAS NOTIFIED OF THE EVENT VIA A NOTIFICATION FROM MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (MHRA). MHRA DOES NOT HAVE PERMISSION TO PROVIDE CUSTOMER CONTACT INFORMATION. THEREFORE, NO ADDITIONAL INFORMATION WAS ABLE TO BE PROVIDED. REVIEWS OF DOCUMENTATION INCLUDING THE COMPLAINT HISTORY, DRAWING, QUALITY CONTROL PROCEDURES, SPECIFICATIONS, MANUFACTURING INSTRUCTIONS (MI), AND INSTRUCTIONS FOR USE (IFU) WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS UNABLE TO BE COMPLETED DUE TO A LACK OF LOT INFORMATION. BASED ON THE AVAILABLE INFORMATION, COOK HAS CONCLUDED THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION AND THAT THERE IS NO EVIDENCE SUGGESTING NONCONFORMING PRODUCT EXISTS EITHER IN HOUSE OR IN THE FIELD. COOK ALSO REVIEWED PRODUCT LABELING. THE IFU PACKAGED WITH THE DEVICE CONTAINS THE FOLLOWING IN RELATION TO THE REPORTED FAILURE MODE: PRECAUTIONS ¿ EXCESSIVE FORCE SHOULD NOT BE USED TO MANIPULATE OR RETRIEVE FOREIGN OBJECTS ¿ VISUALLY INSPECT THE PRODUCT BEFORE USE TO ENSURE IT IS UNDAMAGED. FOR EXAMPLE, THE SHAFT SHOULD BE FREE OF KINKS. ¿ ALWAYS CHECK FIT THROUGH THE INTENDED GUIDING CATHETER OR INTRODUCER SHEATH PRIOR TO USE. POTENTIAL ADVERSE EVENTS ¿ DEVICE AND FOREIGN BODY ENTRAPMENT HOW SUPPLIED SUPPLIED STERILIZED BY ETHYLENE OXIDE GAS IN PEEL-OPEN PACKAGES. INTENDED FOR ONE-TIME USE. STERILE IF PACKAGE IS UNOPENED AND UNDAMAGED. DO NOT USE THE PRODUCT IF THERE IS DOUBT AS TO WHETHER THE PRODUCT IS STERILE STORE IN A DARK, DRY, COOL PLACE. AVOID EXTENDED EXPOSURE TO LIGHT. UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED. INSTRUCTIONS FOR USE 5. WHILE HOLDING THE FLEXOR SHEATH IN POSITION, LOOSEN TUOHY-BORST AND ADVANCE THE INNER CATHETER THROUGH THE FLEXOR SHEATH UNTIL THE SNARE EMERGES FROM THE DISTAL TIP. NOTE: THE SNARE WILL EXPAND UPON EMERGENCE FROM THE FLEXOR SHEATH. 6. POSITION THE RETRIEVER SO THAT THE FOREIGN BODY, SUCH AS A WIRE GUIDE OR CATHETER, IS POSITIONED WITH THE SNARE. WHILE MAINTAINING THE SNARE POSITION, SLIDE THE FLEXOR SHEATH FORWARD TO CAPTURE THE FOREIGN BODY. 7. TIGHTEN THE TUOHY-BORST TO MAINTAIN TENSION ON THE CATHETER CONTROLLING THE FOREIGN BODY, WITHDRAW THE RETRIEVER, INCLUDING THE SNARE AND FLEXOR SHEATH ASSEMBLY, TO A PERIPHERAL LOCATION. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED, AND THE RESULTS OF THE INVESTIGATION A DEFINITIVE ROOT CAUSE FOR THIS EVENT COULD NOT BE ESTABLISHED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TOA DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.