COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET
Report
- Report Number
- 3002808486-2021-02000
- Event Type
- Malfunction
- Date Received
- December 6, 2021
- Date of Event
- November 15, 2021
- Report Date
- March 8, 2022
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- DTK
- UDI-DI
- 10827002345048
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). SIMILAR TO DEVICE MARKETED UNDER PMA/510(K): K171712. INVESTIGATION IS STILL IN PROGRESS.
MANUFACTURER REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: RESISTANCE WAS FELT WHEN ADVANCING THE FEMORAL INTRODUCER WITH FILTER THROUGH THE SHEATH. THE FEMORAL INTRODUCER WITH FILTER WAS REMOVED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE. THE COMPLETE UNI DEVICE WAS RETURNED FOR INVESTIGATION. THE INTRODUCER DILATOR WAS KINKED 454 AND 506MM FROM DISTAL END. THE CELECT-PT FILTER WAS SEVERELY DAMAGED WITH THREE FILTER LEGS BEING KINKED/CROSSED AND ONE OF THEM PUSHING UPWARDS AGAINST THE CLIP BUSHING, LIKELY BECAUSE THE FILTER WAS REMOVED ¿FROM THE SHEATH IMMEDIATELY¿. ON THE FEMORAL INTRODUCER THE RED LOCKING MECHANISM WAS PRESSED, IE THE SYSTEM WAS UNLOCKED. NO NONCONFORMANCES WERE NOTED ON THE INTRODUCER SHEATH AND THE FEMORAL INTRODUCER COULD BE ADVANCED WITHOUT RESISTANCE. BASED ON THESE FINDINGS THE EXACT REASON FOR THE DIFFICULTIES ENCOUNTERED, WHEN ATTEMPTING TO ADVANCE THE FEMORAL INTRODUCER CANNOT BE DETERMINED, BUT REFERENCE IS MADE TO THE INSTRUCTIONS FOR USE WARNING AGAINST ROTATING THE PRELOADED FILTER INSIDE THE INTRODUCER SYSTEM DURING ADVANCEMENT. ALSO, FOLLOWING ADVANCEMENT DIFFICULTIES THE IFU CAUTION THAT ATTEMPTS TO RETRACT THE PRE-EXPANDED FILTER COULD DAMAGE THE SECONDARY FILTER LEGS OR THE CAVAL WALL. THERE ARE ADEQUATE CONTROLS IN PLACE TO ENSURE THAT THE DEVICE IS MANUFACTURED TO SPECIFICATIONS. IN ADDITION, NO OTHER LOT RELATED COMPLAINTS HAVE BEEN RECEIVED FROM THE FIELD. IT IS THEREFORE CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN FIELD. 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# PR(B)(4). SIMILAR TO DEVICE MARKETED UNDER PMA/510(K): K171712. INVESTIGATION IS STILL IN PROGRESS.
DESCRIPTION OF EVENT ACCORDING TO THE INITIAL REPORTER: THE CASE WAS PLANNED TO PLACE A IVC FILTER THROUGH FEMORAL VEIN. THEY FOUND HIGH RESISTANCE DURING ADVANCING THE FILTER DELIVERY SYSTEM THROUGH THE SHEATH, SO THEY REMOVED THE FILTER DELIVERY SYSTEM FROM THE SHEATH IMMEDIATELY. THEY REOPENED ANOTHER NEW KIT AND ADVANCING THE NEW FEMORAL DELIVERY KIT. FINALLY, THE IVC FILTER WAS PLACED SUCCESSFULLY. PATIENT OUTCOME: NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
DESCRIPTION OF EVENT ACCORDING TO THE INITIAL REPORTER: THE CASE WAS PLANNED TO PLACE A IVC FILTER THROUGH FEMORAL VEIN. THEY FOUND HIGH RESISTANCE DURING ADVANCING THE FILTER DELIVERY SYSTEM THROUGH THE SHEATH, SO THEY REMOVED THE FILTER DELIVERY SYSTEM FROM THE SHEATH IMMEDIATELY. THEY REOPENED ANOTHER NEW KIT AND ADVANCING THE NEW FEMORAL DELIVERY KIT. FINALLY, THE IVC FILTER WAS PLACED SUCCESSFULLY. PATIENT OUTCOME: NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1832211 | COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET | DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR | DTK | WILLIAM COOK EUROPE | E4068555 | 10827002345048 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |