GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
Report
- Report Number
- 1820334-2024-01097
- Event Type
- Malfunction
- Date Received
- August 20, 2024
- Date of Event
- August 7, 2024
- Report Date
- October 28, 2024
- Manufacturer
- COOK INC
- Product Code
- MMX
- UDI-DI
- 10827002132877
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. 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.
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. ADDITIONAL INFORMATION: B5, D9, D10, H3. 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.
SUMMARY OF EVENT: AS REPORTED, DURING RETRIEVAL OF AN UNKNOWN INFERIOR VENA CAVA FILTER, A GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET'S SNARE BROKE. THE SHEATH'S HUB ALSO SEPARATED. ANOTHER DEVICE OF THE SAME TYPE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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 ON 22AUG2024. ANOTHER MANUFACTURER'S FILTER, WHICH HAD BEEN IN PLACE FOR THREE MONTHS, WAS BEING RETRIEVED AT THE TIME OF THE EVENT. THE FILTER WAS NOT EMBEDDED AND HAD NOT PERFORATED THE INFERIOR VENA CAVA. A NEW SNARE WAS USED TO RETRIEVE THE FILTER WITHOUT DIFFICULTY. CORRECTED INFORMATION: H6 (ANNEXES A & G). 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, THE BLUE RETRIEVAL SHEATH, AND THE RETRIEVAL LOOP SYSTEM WITH A NON-COOK THREE-WAY STOPCOCK WERE RETURNED. THE HUB HAD SEPARATED FROM THE BLUE SHEATH AND THE RETRIEVAL LOOP HAD FRACTURED. THESE FINDINGS, COMBINED WITH SEVERE INDENTATIONS IN THE TIP OF THE LOOP SYSTEM CATHETER AND TIP OF THE RETRIEVAL CATHETER, SUGGEST STRONG MANIPULATION WAS USED IN ATTEMPT TO COLLAPSE AND RETRIEVE THE FILTER. THE INCORRECT PLACEMENT OF THE PIN VISE ON THE LOOP WIRE ALSO PREVENTED THE LOOP FROM FULLY EXPANDING; HOWEVER, IT IS UNKNOWN IF THE PIN VISE WAS MOVED AND TIGHTENED AFTER THE UNSUCCESSFUL RETRIEVAL ATTEMPT. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO RELEVANT NON-CONFORMANCES ON THE LOT. A REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL COMPLAINTS FOR THIS LOT NUMBER. THE PRODUCT IFU STATES THAT THE DEVICE IS INTENDED FOR RETRIEVAL OF TULIP AND CELECT FILTERS AND WARNS THAT EXCESSIVE FORCE SHOULD NOT BE EXERTED TO RETRIEVE THE FILTER. ALSO, IT IS SPECIFIED TO ENSURE CORRECT PLACEMENT OF THE PIN VISE DURING PREPARATION. THE IFU ALSO INSTRUCTS TO ENSURE THAT THE RETRIEVAL LOOP IS FULLY EXPANDED WHEN THE PIN VISE IS TIGHTENED DURING PREPARATION. 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. 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 EVENT, AS THE COMPLAINT DEVICE WAS USED FOR RETRIEVAL OF ANOTHER MANUFACTURER¿S FILTER. THE IFU STATES THAT THE DEVICE IS INTENDED FOR RETRIEVAL OF TULIP AND CELECT FILTERS. 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.
AS REPORTED, DURING RETRIEVAL OF AN UNKNOWN INFERIOR VENA CAVA FILTER, A GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET'S SNARE BROKE. THE SHEATH'S HUB ALSO SEPARATED. ANOTHER DEVICE OF THE SAME TYPE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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 THREE MONTHS, WAS BEING RETRIEVED AT THE TIME OF THE EVENT. THE FILTER WAS NOT EMBEDDED AND HAD NOT PERFORATED THE INFERIOR VENA CAVA. A NEW SNARE WAS USED TO RETRIEVE THE FILTER WITHOUT DIFFICULTY.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1026625 | GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET | MMX DEVICE, PERCUTANEOUS RETRIEVAL | MMX | COOK INC | G13287 | 16023302 | 10827002132877 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | BARD DENALI FILTER |