MAUDE Adverse Event Report: WILLIAM COOK EUROPE UNKNOWN; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number UNKNOWN

Device Problems Difficult to Remove (1528); Activation Failure (3270)

Patient Problem No Information (3190)

Event Date 11/08/2019

Event Type  malfunction  

Manufacturer Narrative

Manufacturer ref# (b)(4).Catalog# is unknown but referred to as cook celect platinum filter.Pma/510(k) k171712.Investigation is still in progress.

Event Description

Description of event according to initial reporter: filter not opening when they deployed it in clot.The physician said the ivc and iliacs were full of clot.He decided to still place filter from the femoral vein below the renals in the ivc.He went through the clot with the sheath, deployed the filter and the legs didn¿t open.He went jugular with a snare and tried to retrieve the filter.He could get the filter to collapse into the sheath so he just pulled it out, with the sheath (filter sticking out).After taking it out filter was found to be full of clot which is why it wouldn¿t collapse into the 8fe sheath.The physician understand that the filter didn¿t open due to deploying it into a large amount of clot." patient outcome: they removed the filter the same day.Patient is still in the hospital due to other health issues not related to the filter.No additional procedures were required.

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 a filter placed from femoral approach would not expand and due to clots, it could not be collapsed and was retrieved by snare from jug approach ¿with filter sticking out¿.No harm to patient reported.The celect-pt filter was returned and evaluation revealed no nonconformance, ie shape, various measurements, and diagonal distances were according to specifications.However, based on the information provided the ivc and iliac ¿were full of clot¿ and the filter could not be collapsed for proper retrieval since it was ¿full of clot¿, too and it is previously seen that the filter legs may be somehow obstructed from fully expanding due to e.G.Ivc anatomical conditions, clots or if the filter is not placed in ivc.There are adequate controls in place to ensure that this type of device is manufactured to specifications.Cook medical will continue to monitor for similar events.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.

• Brand Name: UNKNOWN
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 9408713
• MDR Text Key: 189914110
• Report Number: 3002808486-2019-01889
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2020
• Date Manufacturer Received: 07/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 89 YR