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

Catalog Number UNKNOWN

Device Problem Difficult or Delayed Activation (2577)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Manufacturer ref# (b)(4).Blank fields on this form indicate the information is unknown or unavailable.Catalog# is unknown but referred to as unknown femoral filter.Investigation is still in progress.

Event Description

Description of event according to initial reporter: unknown femoral filters.Complaint is that they've had trouble deploying the filters.Release buttons get stuck.Devices are not letting go of all the legs.

Manufacturer Narrative

Manufacturer ref# (b)(4).Summary of investigational findings: it was reported that an unknown femoral filter device (suspect celect-pt) had trouble deploying the filter.Release button got stuck and the device didn¿t let go of all the filter legs.No patient harm indicated so it is assumed that the filter was placed correctly eventually.Cook was unable to conduct a review of the device history record, as the lot number of the complaint device was not provided for the investigation.According to the instruction for use excessive force should not be exerted in placement of the filter.Based on the limited provided information it is unknown what caused the reported event.It is possible that during the release of the filter excessive force was used which resulted in the described event, but this is only speculation.No evidence to suggest that the device is not manufactured according to specification 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.

Event Description

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

• 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: 11861561
• MDR Text Key: 254541264
• Report Number: 3002808486-2021-01246
• 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: 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2021
• 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?: No
• Date Manufacturer Received: 07/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1