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

Catalog Number GTRS-200-RB

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/19/2020

Event Type  malfunction  

Event Description

As reported, during retrieval of a cook celect filter, which had been in place for seven years, a gunther tulip vena cava filter retrieval set's sheath "fell apart".An unspecified pigtail catheter was exchanged for the gunther tulip ivc filter retrieval set.The hook of the filter was snared, and the user attempted to advance the sheath over the filter.The first sheath "fell apart" due to filter ingrowth.A 0.035-inch wire was advanced and another retrieval set was used to successfully retrieve the filter.All information related to the cook celect filter has been previously reported under mdr 3002808486-2022-00079.

Manufacturer Narrative

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

Manufacturer Narrative

Summary of event: as reported, during retrieval of a cook celect filter, which had been in place for seven years, a gunther tulip vena cava filter retrieval set's sheath "fell apart".An unspecified pigtail catheter was exchanged for the gunther tulip ivc filter retrieval set.The hook of the filter was snared, and the user attempted to advance the sheath over the filter.The first sheath "fell apart" due to filter ingrowth.A 0.035-inch wire was advanced, and another retrieval set was used to successfully retrieve the filter.All information related to the cook celect filter has been previously reported under mdr 3002808486-2022-00079.Investigation evaluation: reviews of the instructions for use (ifu), manufacturing instructions, and quality control procedures were conducted during the investigation.The complaint device was not returned to cook for investigation.The lot number is unknown; therefore, a review of the device history record could not be conducted.The product ifu warns that excessive force should not be exerted to retrieve the filter.The information provided upon review of the dmr, dhf, and ifu suggests that there is evidence the device was manufactured to specification.There is no evidence of non-conforming devices in-house or in the field.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Based on the information provided and the results of the investigation, cook could not determine a cause for the failure mode at this time.The risk analysis for this failure mode was reviewed and no additional escalation was required.The appropriate personnel have been notified and cook will continue to monitor for similar events.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

No additional information has been received since the last report was submitted.

• 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: 13928428
• MDR Text Key: 292588394
• Report Number: 1820334-2022-00467
• 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: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2022
• 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: 04/18/2022
• 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
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 118 KG