GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET

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

SUMMARY OF EVENT: AS REPORTED, DURING RETRIEVAL OF AN UNKNOWN FILTER, A GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET'S SNARE BROKE. WHILE ATTEMPTING TO RETRIEVE THE FILTER, THE PHYSICIAN REPORTEDLY "LASSOED IN THE RETRIEVAL SET" AND APPLIED TOO MUCH BACK TENSION ON THE SNARE, CAUSING IT TO BREAK. THE PHYSICIAN STATED THAT SHE WAS PULLING TOO HARD. ANOTHER SNARE OF THE SAME TYPE WAS USED TO RETRIEVE THE BROKEN SNARE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION WAS RECEIVED 22AUG2024. ANOTHER MANUFACTURER'S FILTER, WHICH HAD BEEN IN PLACE FOR OVER ONE YEAR, WAS BEING RETRIEVED AT THE TIME OF THE EVENT. INVESTIGATION EVALUATION: REVIEWS OF THE 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 DEVICE WAS RETURNED WITHOUT THE WHITE TUOHY-BORST SIDE-ARM ADAPTER, AND THE LOOP HAD FRACTURED. INDENTATIONS IN THE TIP OF THE LOOP SYSTEM CATHETER WERE NOTED, SUGGESTING STRONG MANIPULATION WAS USED TO COLLAPSE AND RETRIEVE THE FILTER. THE PLACEMENT OF THE PIN VISE ON THE LOOP WIRE PREVENTED THE LOOP FROM FULLY EXPANDING, HOWEVER; IT IS UNKNOWN IF THIS WAS MOVED/TIGHTENED PRIOR OR POST PROCEDURE. COOK WAS UNABLE TO COMPLETE A DEVICE HISTORY RECORD OR COMPLAINT HISTORY REVIEW DUE TO A LACK OF LOT INFORMATION FROM THE USER FACILITY. PER THE INSTRUCTIONS FOR USE, THE DEVICE HAS BEEN DESIGNED FOR RETRIEVAL OF IMPLANTED GÜNTHER TULIP AND COOK CELECT VENA CAVA FILTERS. ALSO, THE IFU INSTRUCTS THAT DURING PREPARATION, TO ENSURE THAT THE RETRIEVAL LOOP IS FULLY EXPANDED WHEN THE PIN VISE IS TIGHTENED. IT ALSO 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, IFU, AND INVESTIGATION OF THE RETURNED DEVICE SUGGESTS THAT THERE IS EVIDENCE THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THERE IS NO EVIDENCE OF NON-CONFORMING DEVICES IN-HOUSE OR IN THE FIELD. BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT OFF-LABEL USE CONTRIBUTED TO THIS INCIDENT. ANOTHER MANUFACTURER'S FILTER WAS RETRIEVED, CONTRARY TO THE INSTRUCTIONS FOR USE (IFU). IN ADDITION, THE IFU STATES THAT EXCESSIVE FORCE SHOULD NOT BE EXERTED TO RETRIEVE THE FILTER. IN THIS CASE, THE USER STATED THAT THEY "APPLIED TOO MUCH BACK TENSION ON THE SNARE, CAUSING THE SNARE TO BREAK". 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.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B5, D10, H3: DEVICE EVALUATED BY MFG = OTHER (81) - DEVICE EVALUATION HAS BEGUN; HOWEVER, A CONCLUSION IS NOT YET AVAILABLE. 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

ADDITIONAL INFORMATION WAS RECEIVED 22AUG2024. ANOTHER MANUFACTURER'S FILTER, WHICH HAD BEEN IN PLACE FOR OVER ONE YEAR, WAS BEING RETRIEVED AT THE TIME OF THE EVENT.

Additional Manufacturer Narrative

BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. E3: OCCUPATION = NURSE MANAGER. 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.

Description of Event or Problem

AS REPORTED, DURING RETRIEVAL OF AN UNKNOWN FILTER, A GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET'S SNARE BROKE. WHILE ATTEMPTING TO RETRIEVE THE FILTER, THE PHYSICIAN REPORTEDLY "LASSOED IN THE RETRIEVAL SET" AND APPLIED TOO MUCH BACK TENSION ON THE SNARE, CAUSING IT TO BREAK. THE PHYSICIAN STATED THAT SHE WAS PULLING TOO HARD. ANOTHER SNARE OF THE SAME TYPE WAS USED TO RETRIEVE THE BROKEN SNARE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.