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

Catalog Number UNKNOWN

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Event Description

Description of event according to initial reporter: a female patient had a cook celect vena cava filter implanted approximately 10 years prior due to trauma sustained from a motorcycle accident.Upon retrieval the physician noted that one leg had fractured and embedded into the intima layer of the ivc.The physician tried to pull the fractured leg out with no success as it would not move.The physician decided to leave the leg and was able to retrieve the remainder of the filter.The physician stated they were not concerned about migration as it would not move when attempted to remove.Patient outcome: did any unintended section of the device remain inside the patient¿s body? yes - one leg is embedded in the intima layer of the ivc.

• 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: 10253364
• MDR Text Key: 198296421
• Report Number: 3005580113-2020-00378
• 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: 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Distributor Facility Aware Date: 06/29/2020
• Event Location: Hospital
• Date Report to Manufacturer: 07/09/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/09/2020
• 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): Other