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

Catalog Number UNKNOWN

Device Problems Entrapment of Device (1212); Appropriate Term/Code Not Available (3191)

Patient Problems Death (1802); Fistula (1862); Perforation of Vessels (2135)

Event Type  Death  

Manufacturer Narrative

This event has been reported by the manufacturer under mdr# 3002808486-2019-01727.

Event Description

It is alleged that "[pt] received a cook celect filter on (b)(6) 2011.Alleged death, embedment, perforation and enterovenous fistula between ivc and duodenum.Patient death on (b)(6) 2016".Hospital and medical records have been requested but not yet provided.

• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 9262030
• MDR Text Key: 164479550
• Report Number: 3005580113-2019-00672
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• Is this an Adverse Event Report?: Yes
• 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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/31/2019
• Distributor Facility Aware Date: 10/10/2019
• Event Location: Other
• Date Report to Manufacturer: 10/08/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death