COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET
Report
- Report Number
- 3002808486-2025-00201
- Event Type
- Injury
- Date Received
- September 11, 2025
- Date of Event
- September 4, 2025
- Report Date
- December 3, 2025
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- DTK
- UDI-DI
- 10827002345055
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SG
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
MANUFACTURERS REF# (B)(4). BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. G4) SIMILAR TO DEVICE MARKETED UNDER PMA/510(K): K233680 INVESTIGATION IS STILL IN PROGRESS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21CFR 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¿S REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: THE CELECT-PT FILTER APPEARED SIGNIFICANTLY TILTED AFTER PLACEMENT FROM JUGULAR APPROACH. THE FILTER WAS REMOVED AND REPLACED WITH NO REPORTED ADVERSE EFFECTS ON THE PATIENT. THE COMPLAINT REPORTED BY THE USER WAS CONFIRMED. THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR SALES REPRESENTATIVE TESTIMONY. PHOTOGRAPHIC EVIDENCE WAS RETURNED FOR EVALUATION. THE REVIEW OF THE PHOTOS DETERMINED THE FOLLOWING: TWO PHOTOS OF THE CELECT-PT FILTER WITH AN INTACT HOOK, BUT TWO OR MORE MISPLACED SECONDARY FILTER LEGS. A REVIEW OF THE MANUFACTURING RECORDS AND/OR SPECIFICATIONS DID NOT REVEAL ANY DISCREPANCIES/NONCONFORMANCES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THE INVESTIGATION CONCLUDES THE COMPLAINT DEVICE WAS MANUFACTURED TO SPECIFICATION. THE REVIEW OF THE RELEVANT MANUFACTURING RECORDS CONFIRMS THE FAILURE HAS NOT PREVIOUSLY OCCURRED FOR THIS MANUFACTURING LOT. THERE IS NO EVIDENCE TO SUGGEST THAT THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE AND/OR LABEL. A DEFINITIVE CAUSE COULD NOT BE DETERMINED FROM THE INVESTIGATION. POSSIBLE CAUSES ARE ADVANCEMENT DURING FILTER RELEASE OR MANIPULATION DURING ATTEMPT TO RE-SHEATH. AN INTERNAL ACTION IS NOT DEEMED NECESSARY AT THIS TIME. TRENDING WILL MONITOR IF ANY FUTURE ACTIONS ARE REQUIRED. AFTER CONSIDERING THIS EVENT THE RISK ASSOCIATED WITH THE USE OF THIS DEVICE IS STILL DEEMED ADEQUATE. 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.
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE CELECT FILTER APPEARED FINE BEFORE INSERTION, BUT AFTER BEING INTRODUCED TO THE PATIENT, IT APPEARED SIGNIFICANTLY TILTED ON THE IMAGING SCREEN. AS A RESULT, THE DOCTOR HAD TO REMOVE IT AND REPLACE IT WITH A NEW FILTER TO ENSURE PATIENT SAFETY. PATIENT OUTCOME: NO HARM TO PATIENT REPORTED
ADDITIONAL INFORMATION RECEIVED 09SEP2025: THE PROCEDURAL APPROACH WAS JUGULAR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2365993 | COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET | DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR | DTK | WILLIAM COOK EUROPE | G34505 | E4721078 | 10827002345055 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Required Intervention |