MAUDE Adverse Event Report: WILLIAM COOK EUROPE COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number G34505

Device Problems Dent in Material (2526); Difficult to Advance (2920)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/03/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation is still in progress.

Event Description

Description of event according to initial reporter: a (b)(6) year old male underwent a vena cava filter implant.The physician was able to gain access; when inserted the filter into sheath up to approximately 5cm the filter would not advance any further.The filter did get past the valve.The physician removed the device and the company representative, who was present during the procedure, was able to provide another of the same device to complete the procedure with no further complications.Patient outcome: there was no harm to the patient and no additional procedure required.

Event Description

Additional information received (b)(6)2019 from medwatch (b)(4)."the filter was unable to be passed through the sheath to be deployed in patient.There is a sheath that inserted through the femoral vein into the ivc.The filter is then passed through the sheath to be deployed into the ivc of the patient.The filter would not pass through the sheath and had to be pulled out.A replacement ivc filter was brought in and the new sheath was exchanged out and the new filter was deployed into the patient.There was no harm to the patient.The filter was being placed during ivc filter placement under x-ray".

Manufacturer Narrative

Exemption number(b)(4).William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Manufacturer ref#(b)(4).G1) name and address for importer site: cook medical incorporated (cmi) (b)(4).Registration no.:(b)(4).H11) corrected data compared with medwatch report (b)(4): b3)dec-2018 b4)dec-2018 d1cook celect patinum d2b) unk d3) william cook europe aps bloomington, in d4) sep-2021 d10) dec-2018 e1) erin lee (b)(4).E2)yes e3) risk manager f9) 1 days f14) william cook europe aps (b)(4).Summary of investigational findings: investigation is based on event description and returned device.It was reported that the filter was advanced through the valve and into the sheath, but stuck after approx.5cm.Device was removed and replaced with no harm to the patient.The complete device was returned.The primary filter legs were still loaded in the femoral cup, but the secondary legs were curled upwards and severely damaged, probably because the filter was retrieved through the valve.On the femoral introducer a minor kink was noted next to the cup.No damages noted on the sheath.During investigation the dilator could be advanced through the sheath without resistance and since the outer diameter of the dilator is larger than the collapsed/folded filter, the exact reason why the filter could not be advanced through the sheath cannot be determined, unless the kinked introducer did not support the filter advancement and contributed to the event.No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that it did not perform as intended.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.

• Brand Name: COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 8168516
• MDR Text Key: 130457628
• Report Number: 3002808486-2018-01525
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002345055
• UDI-Public: (01)10827002345055(17)210912(10)E3772627
• Combination Product (y/n): N
• PMA/PMN Number: K121629
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 02/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/12/2021
• Device Model Number: G34505
• Device Catalogue Number: IGTCFS-65-1-UNI-CELECT-PT
• Device Lot Number: E3772627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2018
• Distributor Facility Aware Date: 12/03/2018
• Device Age: 3 MO
• Date Manufacturer Received: 01/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR