COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET
Report
- Report Number
- 3002808486-2022-00016
- Event Type
- Death
- Date Received
- January 11, 2022
- Date of Event
- January 3, 2022
- Report Date
- July 18, 2022
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- DTK
- UDI-DI
- 10827002343105
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
MANUFACTURER REF#:(B)(4). BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. CATALOG# IS UNKNOWN BUT REFERRED TO AS COOK CELECT FILTER. SIMILAR TO DEVICE MARKETED UNDER PMA/510(K): K171712. INVESTIGATION IS STILL IN PROGRESS.
MANUFACTURER REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: THE PATIENT RECEIVED A CELECT-PT FILTER FOR PERSISTENT PULMONARY EMBOLISM (PE) DESPITE ANTICOAGULATION. THIS IS IN LINE WITH THE DEVICE¿S INTENDED USE AS DESCRIBED IN THE IFU, NAMELY ¿FAILURE OF ANTICOAGULANT THERAPY IN THROMBOEMBOLIC DISEASE ¿. THE PHYSICIAN NOTED THAT THE PATIENT WAS VERY BREATHLESS PRIOR TO THE PROCEDURE WITH A HYPERDYNAMIC JUGULAR VEIN SUGGESTING LARGE CHANGES IN INTRATHORACIC PRESSURE DURING BREATHING. THE PATIENT WAS SUPINE DURING INSERTION AND IT WAS THOUGHT SOME AIR ENTRAINMENT HAPPENED AS THE FILTER SHEATH WAS INSERTED OVER AN .035 WIRE GUIDE. THE DILATOR AND .035 WIRE WERE IN PLACE AT THIS POINT BUT THE THREE-WAY TAP ON THE SHEATH WAS DETACHED. THREE TO FOUR SUCKING NOISES WERE HEARD FOR 3-4 SECONDS AS THE SHEATH WAS INSERTED. THE PATIENT¿S OXYGEN SATURATION DROPPED SOON AFTER THIS AND SUBSEQUENTLY PASSED AWAY AFTER THE PROCEDURE. THE CLINICAL TEAM KEPT THE DELIVERY SYSTEM IN THEIR DEPARTMENT AND PERFORMED SOME BENCH TESTING SIMULATIONS AND AN INCIDENT REPORT WAS SUBMITTED TO THE MHRA, IN WHICH IT WAS STATED THAT ¿THE THREE-WAY TAP MAY HAVE FUNCTIONED AS EXPECTED¿. THE INTRODUCER SYSTEM (SHEATH, DILATOR, AND JUGULAR INTRODUCER) WAS RETURNED AND THE INVESTIGATION REVEALED SEVERAL MINOR KINKS IN THE SHEATH AS WELL AS IN THE DILATOR. THE JUGULAR INTRODUCER HAD A LOT OF BLOOD INSIDE THE PROTECTION SHEATH, WHICH CAUSED THE GRASPING HOOK TO STICK, BUT AFTER SOAKED IN WATER, IT MOVED FREELY AND THE RELEASE MECHANISM WORKED AS INTENDED. THE DILATOR AS WELL AS JUGULAR INTRODUCER COULD BE ADVANCED THROUGH THE SHEATH WITHOUT DIFFICULTIES AND WITHOUT ANY ¿NOISES¿. A DOCUMENTED DESCRIPTION OF THE PHYSICIAN¿S TEST WAS PROVIDED, TOO, AND INCLUDED A PHOTO OF ANOTHER COOK CHECK-FLO ASSEMBLY/SIDE-ARM ATTACHED TO THE DILATOR HUB DURING THE TEST. HOWEVER, THIS ASSEMBLY/SIDE-ARM WAS NOT RETURNED, BUT MAY BE THE ONE REFERENCED AS ¿DETACHED¿. IT WAS CONCLUDED THAT OUR DEVICE EVALUATION COULD NOT REPLICATE THE PRESUMED AIR EMBOLISM DURING INSERTION. FROM THE INFORMATION PROVIDED IN THE COMPLAINT, IT APPEARS LIKELY THAT AIR EMBOLISM DID HAPPEN AND CONTRIBUTED TO THE PATIENT¿S DEATH. HOWEVER, THE CLINICAL CONDITION OF THE PATIENT WAS POOR BEFORE THE PROCEDURE, WITH RESPIRATORY DISTRESS NOTED AND LIKELY CAUSED BY SIGNIFICANT PE. OUR OWN BENCH TESTING ON THE SUBJECT DEVICE DID NOT REVEAL ANY AIR EMBOLISM, ALTHOUGH THE HYPERDYNAMIC JUGULAR VEIN WOULD HAVE CAUSED ABNORMAL AND QUICK CHANGES IN JUGULAR VEIN PRESSURE. SUCH PRESSURE CHANGES COULD CONCEIVABLY HAVE SUCKED SOME AIR INTO THE SYSTEM; AND GIVEN THE POOR AND ALREADY COMPROMISED RESPIRATORY STATUS OF THE PATIENT, MAY HAVE CONTRIBUTED TO HIS DEATH. ALTHOUGH NO MALFUNCTION OF THE DEVICE COULD BE CONFIRMED IN OUR TESTING, AIR EMBOLISM IS A KNOWN POTENTIAL COMPLICATION FROM SUCH A PROCEDURE AND ALSO LISTED IN THE IFU. THE UNDERLYING CONDITION ALSO CONTRIBUTED TO THE PATIENT¿S DEATH. THERE ARE ADEQUATE CONTROLS IN PLACE TO ENSURE THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS. IT WAS ASSESSED THAT BECAUSE ANY DISCOVERED NON-CONFORMANCES WERE PROPERLY DISPOSITIONED BEFORE QC RELEASE, THERE IS EVIDENCE THAT THE DHR WAS FULLY EXECUTED. 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# (B)(4). 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: WE PLACED AN IVC FILTER TODAY IN A PATIENT WITH PE DESPITE ANTICOAGULATION AND LIMITED RESPIRATORY RESERVE. THE PATIENT WAS VERY BREATHLESS BEFORE WE STARTED WITH A HYPERDYNAMIC JUGULAR VEIN SUGGESTING LARGE CHANGES IN HIS INTRA-THORACIC PRESSURE DURING BREATHING. THERE WAS THOUGHT TO BE SOME AIR ENTRAINMENT AS THE FILTER SHEATH WAS INSERTED OVER AN 035 WIRE. THE PATIENT WAS SUPINE DURING INSERTION. THE DILATOR AND 035 WIRE WERE IN PLACE AT THIS POINT BUT THE THREE WAY TAP ON THE SHEATH WAS DETACHED. 3-4 SUCKING NOISES OVER A TOTAL OF 3-4 SECONDS OCCURRED AS THE SHEATH WAS INSERTED. THE PATIENT¿S OXYGEN SATURATION DROPPED SOON AFTER THIS. WE HAVE KEPT THE DELIVERY SYSTEM IN OUR DEPARTMENT. WE TRIED TO SIMULATE THE SITUATION ON THE BENCH AND I DON¿T THINK IT IS POSSIBLE FOR AIR TO BE ENTRAINED FROM THE SIDEARM WHEN THE DILATOR IS IN PLACE. WE COULD HOWEVER EASILY ASPIRATE AIR VIA THE GUIDEWIRE LUMEN OF THE CALIBRATED SHEATH DILATOR. THESE TESTS MAY NOT HAVE BEEN PHYSIOLOGICAL. WE TRIED TO INJECT AIR VIA THE END OF THE DILATOR AND IT ONLY ESCAPED VIA THE GUIDEWIRE LUMEN WITH THE TIP OF THE SHEATH IN A LARGE SYRINGE WITH AN UNDERWATER SEAL. PATIENT OUTCOME: PATIENT DIED.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: WE PLACED AN IVC FILTER TODAY IN A PATIENT WITH PE DESPITE ANTICOAGULATION AND LIMITED RESPIRATORY RESERVE. THE PATIENT WAS VERY BREATHLESS BEFORE WE STARTED WITH A HYPERDYNAMIC JUGULAR VEIN SUGGESTING LARGE CHANGES IN HIS INTRA-THORACIC PRESSURE DURING BREATHING. THERE WAS THOUGHT TO BE SOME AIR ENTRAINMENT AS THE FILTER SHEATH WAS INSERTED OVER AN 035 WIRE. THE PATIENT WAS SUPINE DURING INSERTION. THE DILATOR AND 035 WIRE WERE IN PLACE AT THIS POINT BUT THE THREE WAY TAP ON THE SHEATH WAS DETACHED. 3-4 SUCKING NOISES OVER A TOTAL OF 3-4 SECONDS OCCURRED AS THE SHEATH WAS INSERTED. THE PATIENT¿S OXYGEN SATURATION DROPPED SOON AFTER THIS. WE HAVE KEPT THE DELIVERY SYSTEM IN OUR DEPARTMENT. WE TRIED TO SIMULATE THE SITUATION ON THE BENCH AND I DON¿T THINK IT IS POSSIBLE FOR AIR TO BE ENTRAINED FROM THE SIDEARM WHEN THE DILATOR IS IN PLACE. WE COULD HOWEVER EASILY ASPIRATE AIR VIA THE GUIDEWIRE LUMEN OF THE CALIBRATED SHEATH DILATOR. THESE TESTS MAY NOT HAVE BEEN PHYSIOLOGICAL. WE TRIED TO INJECT AIR VIA THE END OF THE DILATOR AND IT ONLY ESCAPED VIA THE GUIDEWIRE LUMEN WITH THE TIP OF THE SHEATH IN A LARGE SYRINGE WITH AN UNDERWATER SEAL. 01FEB2022 PER INCIDENT REPORT SUBMITTED BY CUSTOMER TO MHRA: PATIENT WAS REFERRED FOR AN INFERIOR VENA CAVA FILTER (IVC FILTER) INSERTION. PERFORMED ON THE (B)(6) 2021 PRIOR TO PATIENT DETERIORATING THERE WAS NO OBVIOUS COMPLICATION. HOWEVER, MID PROCEDURE WHEN THE PATIENT DID BEGIN TO DETERIORATE THE ANAESTHETIST RAISED CONCERNS OVER REDUCE PATIENT OXYGEN SATURATIONS. AFTER THE PROCEDURE HAD FINISHED THE PATIENT DETERIORATED RAPIDLY. IT IS SUSPECTED THAT THE THREE WAY TAP MAY HAVE FUNCTIONED AS EXPECTED. PATIENT OUTCOME: PATIENT DIED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1094524 | COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET | DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR | DTK | WILLIAM COOK EUROPE | E4104960 | 10827002343105 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Death |