MAUDE Adverse Event Report: COOK INC GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET; MMX DEVICE, PERCUTANEOUS RETRIEVAL

Catalog Number GTRS-200-RB

Device Problem Difficult to Remove (1528)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

As reported, during an unknown number of procedures, a gunther tulip vena cava filter retrieval set was unable to retrieve a cook celect platinum vena cava filter set.Non-standard techniques and additional devices have been required to complete the retrievals.Per the initial reporter, no further information is available.

Manufacturer Narrative

Pma/510(k) #: k181757.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Manufacturer Narrative

Corrected information: b1, b5, h1: additional information/clarification was received.The complaint device was not a gunther tulip vena cava filter retrieval set, as originally reported, but rather a cook celect platinum navalign uniset vena cava filter set.All future reports will be submitted by william cook europe, as they are the manufacturer for the cook celect platinum navalign uniset vena cava filter set.No additional reports will be submitted by cook inc.For the gunther tulip vena cava filter retrieval set.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

Additional information/clarification was received.The complaint device was not a gunther tulip vena cava filter retrieval set, as originally reported, but rather a cook celect platinum navalign uniset vena cava filter set (william cook europe).

• Brand Name: GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
• Type of Device: MMX DEVICE, PERCUTANEOUS RETRIEVAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 13792526
• MDR Text Key: 291962749
• Report Number: 1820334-2022-00404
• Device Sequence Number: 1
• Product Code: MMX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: GTRS-200-RB
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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