INDY OTW VASCULAR RETRIEVER

Additional Manufacturer Narrative

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

IT WAS REPORTED THAT AN INDY OTW VASCULAR RETRIEVER "BROKE" DURING AN UNKNOWN PROCEDURE. THE MATERIAL WAS REMOVED FROM THE PATIENT, AND THE PROCEDURE CONTINUED WITH OTHER MATERIAL. NO UNINTENDED PORTION OF THE DEVICE REMAINED INSIDE THE PATIENT. AS REPORTED, NO ADVERSE EFFECTS OR ADDITIONAL PROCEDURES FOR THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING THE EVENT HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

Additional Manufacturer Narrative

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

ADDITIONAL INFORMATION RECEIVED ON 22NOV2024.THE COOK INDY OTW VASCULAR RETRIEVER WAS USED ALONG WITH A COMPETITOR'S SHORT 8FR INTRODUCER SHEATH THROUGH THE JUGULAR "TO CATCH AN IMPLANTED CHAMBER CATHETER, LOST IN THE SUPERIOR VENA CAVA". AFTER INTRODUCTION OF THE RETRIEVER THROUGH THE INTRODUCER SHEATH AND SNARE OF THE LOST CHAMBER CATHETER, THE DISTAL PORTION OF THE BLUE INNER CATHETER OF THE INDY OTW VASCULAR RETRIEVER SEPARATED FROM THE GUIDE INSIDE THE INTRODUCER AND HAD TO BE REMOVED. IT WAS UNSPECIFIED HOW IT WAS REMOVED. THERE WAS NO CALCIFICATION OR TORTUOSITY IN THE PATIENT'S VESSELS USED FOR INTRODUCTION OF DEVICES.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D9 - DATE RETURNED TO MFG. CORRECTION: H6 (COMPONENT CODE). INVESTIGATION ¿ EVALUATION: IT WAS REPORTED THAT AN INDY OTW VASCULAR RETRIEVER "BROKE" DURING AN UNKNOWN PROCEDURE. THE DEVICE WAS USED ALONG WITH A COMPETITOR'S SHORT 8FR INTRODUCER SHEATH THROUGH THE JUGULAR "TO CATCH AN IMPLANTED CHAMBER CATHETER, LOST IN THE SUPERIOR VENA CAVA". AFTER INTRODUCTION OF THE RETRIEVER THROUGH THE INTRODUCER SHEATH AND SNARE OF THE LOST CHAMBER CATHETER, THE DISTAL PORTION OF THE BLUE INNER CATHETER OF THE INDY OTW VASCULAR RETRIEVER SEPARATED FROM THE GUIDE INSIDE THE INTRODUCER AND HAD TO BE REMOVED. IT WAS UNSPECIFIED HOW IT WAS REMOVED. THERE WAS NO CALCIFICATION OR TORTUOSITY IN THE PATIENT'S VESSELS USED FOR INTRODUCTION OF DEVICES. NO SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT EXPERIENCE ADVERSE EFFECTS DUE TO THIS OCCURRENCE AND DID NOT REQUIRE ANY ADDITIONAL PROCEDURES. REVIEWS OF DOCUMENTATION INCLUDING THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), DRAWING, INSTRUCTIONS FOR USE (IFU), AND QUALITY CONTROL PROCEDURES, AS WELL AS A VISUAL INSPECTION OF THE RETURNED DEVICE, WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS RETURNED TO COOK FOR INVESTIGATION. PHYSICAL EXAMINATION OF THE RETURNED DEVICE SHOWED: ONE USED DEVICE WAS RECEIVED (CATHETER). THE CATHETER WAS BENT JUST BELOW THE STRAIN RELIEF AND SEPARATED AT APPROXIMATELY 93CM FROM THE STRAIN RELIEF. DETECTIONS ARE IN PLACE TO INSPECT EACH DEVICE PRIOR TO DISTRIBUTION. THEREFORE, COOK CONCLUDES THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. 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 DHR FOR THE REPORTED COMPLAINT DEVICE LOT REVEALED NO NON-CONFORMANCES. A COMPLAINT HISTORY SEARCH IDENTIFIED NO OTHER COMPLAINTS REPORTED FOR THIS LOT. BASED ON THE AVAILABLE INFORMATION, COOK HAS CONCLUDED THAT THERE IS NO EVIDENCE SUGGESTING NONCONFORMING PRODUCT EXISTS EITHER IN HOUSE OR IN THE FIELD. COOK ALSO REVIEWED PRODUCT LABELING. THE DEVICE WAS PACKAGED WITH IFU T_INDYOTW_REV5. THE IFU INCLUDES THE FOLLOWING, WARNINGS, PRECAUTIONS, AND INSTRUCTIONS FOR PROPER PLACEMENT OF THE DEVICE. PRECAUTIONS: MANIPULATION OF THE PRODUCT REQUIRES FLUOROSCOPIC CONTROL. VISUALLY INSPECT THE PRODUCT BEFORE USE TO ENSURE IT IS UNDAMAGED. THE OUTER DIAMETER OF THE DEVICE¿S FLEXOR SHEATH IS 8 FRENCH (2.63 MM) NOMINAL. ALWAYS CHECK FIT THROUGH THE INTENDED GUIDING CATHETER OR INTRODUCER SHEATH PRIOR TO USE. INSTRUCTIONS FOR USE: 4. INSERT THE RETRIEVER OVER-THE-WIRE THROUGH AN IN SITU GUIDING CATHETER OR INTRODUCER SHEATH AND ADVANCE IT TO THE DESIRED POSITION. 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 CAUGHT WITHIN THE SNARE. WHILE MAINTAINING THE SNARE POSITION, SLIDE THE FLEXOR SHEATH FORWARD TO CAPTURE THE FOREIGN BODY. 7. TIGHTEN 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 AND RETRIEVE THE FOREIGN BODY. 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. BASED ON THE INFORMATION PROVIDED, INSPECTION OF THE RETURNED DEVICE, AND THE RESULTS OF THE INVESTIGATION, COOK COULD NOT ESTABLISH A DEFINITIVE CAUSE FOR THE REPORTED FAILURE WITH THE INFORMATION PROVIDED. 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 TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

Description of Event or Problem

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