MAUDE Adverse Event Report: WILLIAM COOK EUROPE GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number G13287

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/09/2019

Event Type  Injury  

Manufacturer Narrative

(b)(6). This report includes information known at this time. A follow-up report will be submitted at the conclusion of the investigation or, when additional relevant information becomes available.

Event Description

It was reported, a (b)(6) male was undergoing an inferior vena cave filter removal (cook celect platinum) when the filter got stuck (endothelialized in 3 months). The snare loop from the gunther tulip vena cava filter retrieval set "broke" after it was engaged with the filter hook. The filter was not able to be removed. There has been no effect on the patient; however part of the loop remained with the filter hook after it broke.

• Brand Name: GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 8636696
• MDR Text Key: 145949889
• Report Number: 1820334-2019-01280
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (Y/N): N
• Reporter Country Code: IN
• PMA/PMN Number: K073374
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,FOREIG

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 12/12/2019

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 05/23/2019
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: G13287
• Device Catalogue Number: GTRS-200-RB
• Device LOT Number: E3734492
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 05/28/2019
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/24/2019
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 06/04/2018
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient TREATMENT DATA

Date Received: 05/23/2019 Patient Sequence Number: 1