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

Model Number G34505

Device Problem Activation Failure (3270)

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

Event Date 05/15/2020

Event Type  Injury  

Manufacturer Narrative

Manufacturers ref# (b)(4).Investigation is still in progress.

Event Description

Description of event according to initial reporter: ivc filter did not deploy properly on [pt].Additional information provided 19may2020: filter was straight vertical without any tilt.One of the legs did not deploy properly and caught two of the other legs, such that only one leg was in proper position.The filter was removed immediately in the same setting since it did not deploy properly.Patient outcome: additional ivc filter required additional procedures and defective filter needed to be removed.No adverse effects was reported on the patient due to this occurrence.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Manufacturers ref# (b)(4).Summary of investigational findings: it was reported that one of the legs did not deploy properly and caught two of the other legs, such that only 1 leg was in proper position.The filter was removed immediately.A new filter was used instead.No adverse events to the patient due to this occurrence.Femoral introducer, jugular introducer, introducer dilator, introducer sheath, celect-pt filter, coaxial retrieval sheath, retrieval loop system and 2x stop cock was returned for product evaluation.All products were curved.Blood/biological matter was present.Red safety button was pressed down at the femoral introducer.It was possible to get the grasping hook out of the jugular introducer.There was a dent at the tip of the protection sheath at the jugular introducer.The grasping hook was without any observed nonconformances.It was possible to get the cut out of the femoral introducer and it was without any observed nonconformances.There was a squeeze mark on the introducer sheath.The blue retrieval sheath had a kink the filter was placed inside the retrieval catheter.One of the secondary legs was kinked.Per the product evaluation, why the filter did not expand correctly is unknown, when it was taken out of the retrieval catheter it was expanding correctly.It was assessed that because no non-conformances were detected, 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.According to instruction for use do not rotate the expanded filter inside the vena cava.Doing so may compromise the performance of the filter.There are adequate controls in place to ensure the device was manufactured to specifications.Based on the provided information and product evaluation the exact cause of the event is unknown.However, the filter expanded correctly when it was taken out of the retrieval sheath during product evaluation.This could indicate that the expanded filter was unintendedly rotated inside vena cava during deployment, which could have led to the reported event.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: 10137091
• MDR Text Key: 194618175
• Report Number: 3002808486-2020-00609
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002345055
• UDI-Public: (01)10827002345055(17)230306(10)E3960983
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/06/2023
• Device Model Number: G34505
• Device Catalogue Number: IGTCFS-65-1-UNI-CELECT-PT
• Device Lot Number: E3960983
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2020
• Date Manufacturer Received: 09/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR