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

Catalog Number UNKNOWN

Device Problem Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/27/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Blank fields on this form indicate the information is unknown or unavailable.Catalog# is unknown but referred to as cook ivc filter investigation is still in progress.

Event Description

Description of event according to initial reporter: "filter came off deployment system prior to physician pushing any delivery buttons.Filter was retrieved and another filter was used to complete the procedure." patient outcome: the patient did not require any additional procedures due to this occurrence.

Manufacturer Narrative

Manufacturers ref# (b)(4).Summary of investigational findings: the filter came off the deployment system prior to the physician pushing any delivery buttons.The filter was retrieved with a retrieval set and another filter set, from the same lot, was used to complete the procedure.No adverse effect on the patient was reported due to this occurrence.No device failure analysis was conducted due to no product return and no imaging available.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.Furthermore, cook was unable to review the device master record, instruction for use and device history file, as the filter type is unknown.It is unknown if the filter was a celect, celect-pt or a tulip filter and if it was a classic or navalign set.Due to insufficient information provided for the investigation, the exact cause for the reported event cannot be established.No evidence suggest that the product was not manufactured to current specifications.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: 10023213
• MDR Text Key: 192372129
• Report Number: 3002808486-2020-00508
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 09/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2020
• 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: 08/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1