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

Catalog Number GTRS-200-RB

Device Problems Break (1069); Retraction Problem (1536); Improper or Incorrect Procedure or Method (2017); Detachment of Device or Device Component (2907)

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

Event Date 08/01/2022

Event Type  malfunction  

Event Description

As reported, during retrieval of an unknown filter, a gunther tulip vena cava filter retrieval set's snare broke off of the wire.Reportedly, the tuohy-borst valve broke off of the black inner sheath and the snare separated from the wire after pulling the filter almost completely into the inner sheath.Because the filter was not entirely within the inner sheath, the entire system was removed and access was lost; however, nothing was left in the patient.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

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.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.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported, during retrieval of an unknown filter, a gunther tulip vena cava filter retrieval set's snare broke off of the wire.Reportedly, the tuohy-borst valve broke off of the black inner sheath and the snare separated from the wire after pulling the filter almost completely into the inner sheath.Because the filter was not entirely within the inner sheath, the entire system was removed and access was lost; however, nothing was left in the patient.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Investigation evaluation: reviews of the instructions for use (ifu) and quality control procedures were conducted during the investigation.A visual inspection of the complaint device was also conducted.The coaxial retrieval sheath and retrieval loop system were returned to cook for evaluation.The introducer dilator was curved.The black inner sheath was curved with a minor indentation in the tip.The tuohy-borst adapter was connected to the hub.The blue outer sheath was twisted near the hub and had been cut in two pieces.The section with the tip was torn from the tip.The loop system catheter was curved.The clear y-fitting was pulled off and the flare of the sheath was damaged.The loop wire was broken in two pieces.The fractured loop wire was observed to have an oval shape at the point of the break, possibly indicating that the loop wire had been severely bent.The lot number was not provided to cook; therefore, a review of the device history record could not be conducted.The product ifu states, ¿while holding the retrieval loop and y-fitting steady, advance the side-arm fitting to collapse the filter into the coaxial retrieval sheath and disengage the anchors of the filter from the caval wall.¿ the ifu also instructs, ¿when the tip of the coaxial retrieval sheath is at the anchors, loosen the hub of the outer sheath and advance the outer sheath forward to cover the entire filter.¿ the information provided upon review of the dmr, ifu, and investigation of the returned device provides 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 has concluded that the cause for the reported failure cannot be determined, though the damage found on the blue outer sheath could indicate that the filter was not sufficiently collapsed prior to advancement of the outer sheath, and separation of the clear y-fitting can occur if excessive force is used.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: 15226699
• MDR Text Key: 305063057
• Report Number: 1820334-2022-01342
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/08/2022

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: GTRS-200-RB
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/01/2022
• Initial Date FDA Received: 08/15/2022
• Supplement Dates Manufacturer Received: 10/10/2022
• Supplement Dates FDA Received: 11/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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 Sex: Male
• Patient Weight: 113 KG