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

Catalog Number UNKNOWN

Device Problems Appropriate Term/Code Not Available (3191); Migration (4003)

Patient Problems Pain (1994); Perforation of Vessels (2135); Disability (2371)

Event Type  Injury  

Event Description

It is alleged that the patient received a cook celect filter on or about (b)(6) 2008.Also alleged: "on or about (b)(6) 2017, it was discovered that the cook filter struts had moved since the filter was placed, with several struts perforating outside of the patient's inferior vena cava." hospital and medical records have been requested but not yet provided.

• 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: 9071213
• MDR Text Key: 160724084
• Report Number: 3005580113-2019-00390
• 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: 09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2019
• 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: 09/16/2019
• Distributor Facility Aware Date: 08/22/2019
• Event Location: Other
• Date Report to Manufacturer: 08/21/2019
• 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): Life Threatening