GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET

Additional Manufacturer Narrative

SUMMARY OF EVENT: AS REPORTED, DURING AN UNKNOWN PROCEDURE, A GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET "SNAPPED". PHOTOS PROVIDED BY THE CUSTOMER SHOW SEPARATION OF THE WIRE LOOP AND SHEATH HUB. THE COOK FILTER HAD BEEN IN PLACE FOR APPROXIMATELY FOUR MONTHS. DURING THE PROCEDURE AS THE WIRE LOOP SNARE CAPTURED THE FILTER HOOK, THE "WHITE PIN" SNAPPED. THE PHYSICIAN USED A CLAMP ON THE SYSTEM TO MAINTAIN ACCESS AND "ENGAGEMENT" WITH THE HOOK. THE USER WAS ABLE TO REMOVE THE ENTIRE SYSTEM, INCLUDING THE FILTER, COMPLETING THE PROCEDURE SUCCESSFULLY. THE PATIENT IS "OKAY". A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT. CORRECTED INFORMATION: H6 (ANNEX A). INVESTIGATION EVALUATION: REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), 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 LOOP WIRE WAS FRACTURED PROXIMALLY, AND THE HUB WAS SEPARATED FROM THE SHEATH. THE TIPS OF THE INNER AND OUTER SHEATHS WERE NOT DAMAGED. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD AND COMPLAINT HISTORY FOUND NO DISCREPANCIES OR ADDITIONAL COMPLAINTS ON THE LOT. THERE IS NO EVIDENCE TO SUGGEST THAT THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE AND/OR LABEL. 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 INVESTIGATION CONCLUDES THE COMPLAINT DEVICE WAS MANUFACTURED TO SPECIFICATION. BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT A DEFINITIVE CAUSE FOR THE EVENT COULD NOT BE DETERMINED; HOWEVER, IT IS POSSIBLE THAT THE USER ATTEMPTED TO REMOVE THE FILTER WITHOUT DISENGAGING THE FILTER ANCHORS FROM THE CAVAL WALL AND PROPERLY COLLAPSING THE FILTER INTO THE SHEATH. 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.

Additional Manufacturer Narrative

ADDITIONAL/CORRECTED INFORMATION: B5, D10. 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. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

Description of Event or Problem

INFORMATION WAS AVAILABLE BUT INADVERTENTLY OMITTED FROM THE PREVIOUS REPORT. THE COOK FILTER HAD BEEN IN PLACE FOR APPROXIMATELY FOUR MONTHS. DURING THE PROCEDURE AS THE WIRE LOOP SNARE CAPTURED THE FILTER HOOK, THE "WHITE PIN" SNAPPED. THE PHYSICIAN USED A CLAMP ON THE SYSTEM TO MAINTAIN ACCESS AND "ENGAGEMENT" WITH THE HOOK. THE USER WAS ABLE TO REMOVE THE ENTIRE SYSTEM, INCLUDING THE FILTER, COMPLETING THE PROCEDURE SUCCESSFULLY. THE PATIENT IS "OKAY".

Additional Manufacturer Narrative

BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. H3: DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN. 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.

Description of Event or Problem

AS REPORTED, DURING AN UNKNOWN PROCEDURE, A GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET "SNAPPED". PHOTOS PROVIDED BY THE CUSTOMER SHOW SEPARATION OF THE WIRE LOOP AND SHEATH HUB. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.