GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
Report
- Report Number
- 1820334-2022-01358
- Event Type
- Injury
- Date Received
- August 18, 2022
- Date of Event
- February 5, 2016
- Report Date
- November 16, 2022
- Manufacturer
- COOK INC
- Product Code
- MMX
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THE EXACT DEVICE IS UNKNOWN; HOWEVER, BASED ON THE DESCRIPTION, THE DEVICE IS BELIEVED TO BE GTRS-200-RB. PMA/510(K) NUMBER = K181757. 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, AN UNSPECIFIED COOK IVC (INFERIOR VENA CAVA) FILTER RETRIEVAL SET WAS USED DURING THE ATTEMPTED RETRIEVAL OF A COOK CELECT INFERIOR VENA CAVA FILTER. THE FILTER WAS REPORTEDLY PENETRATING INTO THE AORTA AND ASSOCIATED THROMBUS WITHIN THE AORTA. NO ACUTE THROMBUS WAS NOTED WITHIN THE IVC FILTER. MINIMAL NARROWING OF THE IVC AT THE LEVEL OF THE FILTER WAS NOTED. THE UNSPECIFIED RETRIEVAL SET WAS PLACED THROUGH THE RIGHT INTERNAL JUGULAR VEIN. THE FILTER WAS SNARED SUCCESSFULLY; HOWEVER, THE LEGS OF THE FILTER COULD NOT BE COMPLETELY RETRACTED INTO THE SHEATH. THE SHEATH REPORTEDLY BUCKLED, AS IT COULD NOT TOLERATE THE STRESS NECESSARY TO REMOVE THE FILTER, AND THE FILTER OF THE HOOK BEGAN TO STRAIGHTEN. THE FILTER WAS RELEASED AND REMAINED IN A RETRACTED POSITION WITHIN THE IVC. A REPEAT CAVOGRAM DEMONSTRATED HIGH-GRADE NARROWING AT THE LEVEL OF THE FILTER. ANGIOPLASTY WAS THEN PERFORMED WITHIN THE STENOSED PORTION OF THE IVC IN RELATION TO THE RETRACTED FILTER. A COMPLETION CAVOGRAM DEMONSTRATED A GOOD RESULT, WITH CONTINUED MILD-TO-MODERATE NARROWING AT THE LEVEL OF THE IVC FILTER. DETAILS INVOLVING THE FILTER HAVE BEEN PREVIOUSLY REPORTED UNDER MDR NUMBER 3002808486-2021-01386. INVESTIGATION EVALUATION: REVIEWS OF THE INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL PROCEDURES WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED TO COOK FOR INVESTIGATION. COOK COULD NOT COMPLETE A REVIEW OF THE DEVICE HISTORY RECORD OR COMPLAINT HISTORY DUE TO THE LACK OF LOT INFORMATION. COOK HAS CONCLUDED THAT THERE ARE ADEQUATE CONTROLS IN PLACE TO ENSURE THAT THIS TYPE OF DEVICE IS MANUFACTURED TO SPECIFICATIONS. THE IFU FOR THIS DEVICE STATES THAT EXCESSIVE FORCE SHOULD NOT BE USED TO RETRIEVE THE FILER AND INSTRUCTS NOT TO PULL THE FILTER BEYOND WHAT IS REQUIRED TO KEEP TENSION ON THE LOOP. THE IFU INSTRUCTS THAT THE FILTER MUST BE COLLAPSED BY ADVANCING THE COAXIAL RETRIEVAL SHEATH BEFORE THE OUTER SHEATH IS ADVANCED TO COVER THE ENTIRE FILTER AND THE RETRIEVAL LOOP SYSTEM PRIOR TO REMOVAL. BASED UPON THE AVAILABLE INFORMATION AND RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT UNINTENDED USER ERROR CONTRIBUTED TO THIS EVENT. THE FILTER LEGS WERE NOT FULLY RETRACTED INTO THE SHEATH AND THE SHEATH BUCKLED AND THE FILTER HOOK STRAIGHTENED DUE TO THE STRESS NECESSARY TO REMOVE THE FILTER. INFORMATION PROVIDED BY THE CUSTOMER SUGGESTS THAT THE FILTER WAS NOT PROPERLY COLLAPSED AND COVERED PRIOR TO RETRIEVAL. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND COOK WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. PER THE QUALITY ENGINEERING 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.
AS REPORTED, AN UNSPECIFIED COOK IVC (INFERIOR VENA CAVA) FILTER RETRIEVAL SET WAS USED DURING THE ATTEMPTED RETRIEVAL OF A COOK CELECT INFERIOR VENA CAVA FILTER. THE FILTER WAS REPORTEDLY PENETRATING INTO THE AORTA AND ASSOCIATED THROMBUS WITHIN THE AORTA. NO ACUTE THROMBUS WAS NOTED WITHIN THE IVC FILTER. MINIMAL NARROWING OF THE IVC AT THE LEVEL OF THE FILTER WAS NOTED. THE UNSPECIFIED RETRIEVAL SET WAS PLACED THROUGH THE RIGHT INTERNAL JUGULAR VEIN. THE FILTER WAS SNARED SUCCESSFULLY; HOWEVER, THE LEGS OF THE FILTER COULD NOT BE COMPLETELY RETRACTED INTO THE SHEATH. THE SHEATH REPORTEDLY BUCKLED, AS IT COULD NOT TOLERATE THE STRESS NECESSARY TO REMOVE THE FILTER, AND THE FILTER OF THE HOOK BEGAN TO STRAIGHTEN. THE FILTER WAS RELEASED AND REMAINED IN A RETRACTED POSITION WITHIN THE IVC. A REPEAT CAVOGRAM DEMONSTRATED HIGH-GRADE NARROWING AT THE LEVEL OF THE FILTER. ANGIOPLASTY WAS THEN PERFORMED WITHIN THE STENOSED PORTION OF THE IVC IN RELATION TO THE RETRACTED FILTER. A COMPLETION CAVOGRAM DEMONSTRATED A GOOD RESULT, WITH CONTINUED MILD-TO-MODERATE NARROWING AT THE LEVEL OF THE IVC FILTER. DETAILS INVOLVING THE FILTER HAVE BEEN PREVIOUSLY REPORTED UNDER MDR NUMBER 3002808486-2021-01386.
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 |
|---|---|---|---|---|---|---|---|
| 2026231 | GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET | MMX DEVICE, PERCUTANEOUS RETRIEVAL | MMX | COOK INC | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | Female | Required Intervention |