GUNTHER TULIP NAVALIGN FEMORAL VENA CAVA FILTER SET
Report
- Report Number
- 3002808486-2022-00136
- Event Type
- Injury
- Date Received
- February 23, 2022
- Date of Event
- January 28, 2022
- Report Date
- May 4, 2022
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- DTK
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
MANUFACTURER REF# (B)(4). CATALOG# IS UNKNOWN BUT REFERRED TO AS COOK GUNTHER TULIP FILTER. PMA/510(K): K171712. INVESTIGATION IS STILL IN PROGRESS.
MANUFACTURER REF# (B)(4). CATALOG# IS UNKNOWN BUT REFERRED TO AS COOK GUNTHER TULIP FILTER. PMA/510(K): K171712. INVESTIGATION IS STILL IN PROGRESS.
MANUFACTURER REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO RE-SHEATH THE FILTER DURING FEMORAL APPROACH. THE FILTER WAS DEPLOYED AND A FEW DAYS LATER IT WAS REMOVED, AND A NEW FILTER WAS PLACED INSTEAD. THE TULIP FILTER WAS RETURNED FOR EVALUATION. THE FILTER LEAVES WERE SEVERELY WRINKLED, ONE OF THE PRIMARY LEGS WAS NOT LEANING AT THE TABLE AND THE HOOK WAS PULLED OUT OF SHAPE. THE CAUSE FOR THE REPORTED FAILURE CANNOT BE CONFIRMED, BUT THIS KIND OF DAMAGE IS SEEN BEFORE IF THE FILTER USED FEMORAL AND TRIED TO BE RE-SHEATHED. COOK WAS UNABLE TO CONDUCT A REVIEW OF THE DEVICE HISTORY RECORD, AS THE LOT NUMBER OF THE COMPLAINT DEVICE WAS NOT PROVIDED FOR THE INVESTIGATION. ACCORDING TO THE INSTRUCTION FOR USE DO NOT RE-SHEATH THE EXPANDED FILTER DURING FEMORAL APPROACH. THERE ARE ADEQUATE CONTROLS IN PLACE TO ENSURE THAT THIS TYPE OF DEVICE IS MANUFACTURED TO SPECIFICATIONS. BASED ON THE PROVIDED INFORMATION AND EVALUATION OF THE FILTER THE CAUSE FOR THE REPORTED EVENT IS MOST LIKELY A RESULT OF THE USER TRIED TO RE-SHEATH AN EXPANDED FILTER DURING FEMORAL APPROACH. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. 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.
MANUFACTURER REF# (B)(4). E3) OCCUPATION REFERRED TO AS ORDERING. INVESTIGATION IS STILL IN PROGRESS. 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 ACCORDING TO INITIAL REPORTER: THE PHYSICIAN TRIED TO RE-SHEATH THE FILTER DURING A FEMORAL DEPLOYMENT WHICH IS OBVIOUSLY NOT AN OPTION. REMOVED A FEW DAYS LATER, DUE TO MANGLED FILTER. PATIENT OUTCOME: ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE PHYSICIAN TRIED TO RE-SHEATH THE FILTER DURING A FEMORAL DEPLOYMENT WHICH IS OBVIOUSLY NOT AN OPTION. REMOVED A FEW DAYS LATER, DUE TO MANGLED FILTER. PATIENT OUTCOME: ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
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 |
|---|---|---|---|---|---|---|---|
| 847271 | GUNTHER TULIP NAVALIGN FEMORAL VENA CAVA FILTER SET | DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR | DTK | WILLIAM COOK EUROPE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |