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

Catalog Number UNKNOWN

Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017)

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

Event Date 05/03/2022

Event Type  malfunction  

Manufacturer Narrative

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

As reported via a medwatch report, during retrieval of an unknown inferior vena cava filter, a snare supplied with a gunther tulip vena cava filter retrieval set broke.Reportedly, the posterior end of the snare's shaft broke after the filter was almost completely retracted into the sheath.No adverse effects to the patient were reported.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Summary of event: as reported via a medwatch report, during retrieval of an unknown inferior vena cava filter, a snare supplied with a gunther tulip vena cava filter retrieval set broke.Reportedly, the posterior end of the snare's shaft broke after the filter was almost completely retracted into the sheath.No adverse effects to the patient were reported.Investigation evaluation: reviews of the instructions for use and quality control procedures were conducted during the investigation.The complaint device was not returned to cook for investigation.Due to lack of lot information, cook could not complete a review of the device history record.Cook reviewed non-conformances related to this complaint from 01jan2019 to 09aug2022, revealing no complaint related non-conformances.A document review was conducted, and cook has concluded that there are adequate controls in place to ensure that this type of device is manufactured to specification.The instructions for use (ifu) states that the filter should be collapsed by the sheath before retrieving/retracting the filter.No device or images were provided for the investigation.This complaint was received via a medwatch report, and customer contact information was not provided.Therefore, clarification regarding what part of the snare ¿broke¿ was unable to be obtained.It is assumed based on the limited information provided that the broken part refers to the pin vise.Based on the provided information, it is unknown why the pin vise broke, but it is stated that the device broke after near complete retraction into the sheath.The ifu instructs the user to collapse the filter with the sheath prior to retrieving/retracting the filter.As such, cook has concluded that unintended use error contributed to this event.If the filter was not collapsed into the sheath before retraction, this could contribute to the described event.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.

• 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: 14714535
• MDR Text Key: 301746204
• Report Number: 1820334-2022-01079
• 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: 09/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/06/2022
• Initial Date FDA Received: 06/16/2022
• Supplement Dates Manufacturer Received: 08/18/2022
• Supplement Dates FDA Received: 09/13/2022
• 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