GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET

Additional Manufacturer Narrative

BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. CORRECTED INFORMATION: H6 (ANNEXES A&G). SUMMARY OF EVENT: AS REPORTED, DURING ATTEMPTED RETRIEVAL OF AN UNSPECIFIED "TULIP" FILTER THAT WAS ORIGINALLY PLACED IN 2018, A GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET'S SHEATH SPLIT. ACCESS WAS OBTAINED IN THE RIGHT INTERNAL JUGULAR VEIN. THE SHEATH SPLIT AS IT WAS ADVANCED OVER THE SNARED FILTER. THE CASE WAS ABORTED; HOWEVER, THERE HAS BEEN NO REPORT OF ANY ADVERSE EFFECTS TO THE PATIENT RESULTING FROM THE ABORTED PROCEDURE. INVESTIGATION EVALUATION: REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL PROCEDURES WERE CONDUCTED DURING THE INVESTIGATION. A VISUAL INSPECTION OF THE COMPLAINT DEVICE WAS ALSO CONDUCTED. THE COMPLAINT DEVICE WAS RETURNED TO COOK FOR INVESTIGATION. THE BLACK RETRIEVAL CATHETER WAS RETURNED INSIDE THE BLUE RETRIEVAL SHEATH. INDENTATIONS NOTED IN THE TIP OF THE BLACK CATHETER AND A 5.5-MILLIMETER FRACTURE IN THE DISTAL TIP OF THE BLUE SHEATH WERE LIKELY CAUSED BY THE PRIMARY FILTER LEGS DURING ATTEMPTS TO COLLAPSE THE FILTER. THE DAMAGE SUGGESTS THAT THE FILTER WAS CAPTURED AS INTENDED, BUT ATTEMPTS TO COLLAPSE THE FILTER FAILED, POSSIBLY RESULTING IN THE ABORTED PROCEDURE. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND FOUR NON-CONFORMANCES ON FOUR DEVICES INVOLVING THE LOT; HOWEVER, THE NON-CONFORMING PRODUCT WAS SCRAPPED OR RE-WORKED. A REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL RELEVANT COMPLAINTS FOR THIS LOT NUMBER. THE PRODUCT IFU WARNS THAT EXCESSIVE FORCE SHOULD NOT BE EXERTED TO RETRIEVE THE FILTER. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE INFORMATION PROVIDED UPON REVIEW OF THE DMR, DHR, IFU, AND INVESTIGATION OF THE RETURNED DEVICE SUGGESTS THAT THERE IS EVIDENCE THE DEVICE WAS MANUFACTURED TO SPECIFICATION. ALTHOUGH NON-CONFORMANCES WERE NOTED ON THE LOT, ALL NON-CONFORMING PRODUCT WAS SCRAPPED OR RE-WORKED, ADEQUATE INSPECTION ACTIVITIES HAVE BEEN ESTABLISHED, THERE IS OBJECTIVE EVIDENCE THAT THE DHR WAS FULLY EXECUTED, AND NO OTHER RELEVANT LOT-RELATED COMPLAINTS HAVE BEEN RECEIVED FROM THE FIELD. THEREFORE, IT WAS CONCLUDED THAT THERE IS NO EVIDENCE THAT ADDITIONAL NON-CONFORMING PRODUCT EXISTS IN HOUSE OR IN THE FIELD. BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT UNINTENDED USER ERROR CONTRIBUTED TO THIS EVENT. THE RISK ANALYSIS FOR THIS FAILURE MODE WAS REVIEWED AND NO ADDITIONAL ESCALATION WAS REQUIRED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND COOK WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. 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.

Description of Event or Problem

AS REPORTED, DURING ATTEMPTED RETRIEVAL OF AN UNSPECIFIED "TULIP" FILTER THAT WAS ORIGINALLY PLACED IN 2018, A GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET'S SHEATH SPLIT. ACCESS WAS OBTAINED IN THE RIGHT INTERNAL JUGULAR VEIN. THE SHEATH SPLIT AS IT WAS ADVANCED OVER THE SNARED FILTER. THE CASE WAS ABORTED; HOWEVER, THERE HAS BEEN NO REPORT OF ANY ADVERSE EFFECTS TO THE PATIENT RESULTING FROM THE ABORTED PROCEDURE.

Additional Manufacturer Narrative

BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. E3: OCCUPATION = INVENTORY CONTROL ANALYST. G4: PMA/510(K) NUMBER = K222254. 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, 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.