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

Catalog Number GTRS-200-RB

Device Problems Fracture (1260); Material Puncture/Hole (1504); 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 09/08/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter occupation = lead tech.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.

Event Description

As reported, during retrieval of a cook celect platinum inferior vena cava filter, the handle and tuohy borst valve separated from the gunther tulip vena cava filter retrieval set's snare, leaving the snare wire exposed.Access was obtained in the right jugular vein, and the device was advanced to the level of the renal veins.Upon snaring the hook of the filter, significant force was applied in opposite directions with the snare and outer sheath to capture the entire filter, as the filter's anchors were embedded.During application of force, the physician inadvertently pulled the handle and tuohy-borst valve off of the snare, leaving the snare wire exposed.Surgical clamps were used to maintain control of the snare wire and contact with the filter hook.The snare system was removed after several unsuccessful attempts to enclose the filter within the sheath.The outer sheath was noted to be kinked and unusable.A loop-snare technique was then attempted to stabilize and capture the filter, utilizing a reverse curve (cook neff) catheter, uniglide exchange wire, 16 french cook performer sheath, and clover snare system.The filter was removed from the patient intact.Return evaluation of the device 21sep2021 showed the sheath bunched near the distal end.Parts of the snare were separated.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.

Event Description

Additional information was received 04oct2021.The filter had been in place for eight to twelve months.The anatomy was not tortuous or abnormal.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.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.

Event Description

During evaluation of the device, fractures/holes were noted on the outer blue sheath.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.H3: device evaluated by mfg = other (81) - device evaluation has begun; however, a conclusion is not yet available.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.

Event Description

There is no new patient or event information to report.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Correction: h6 (annex a and g) description of event: as reported, during retrieval of a cook celect platinum inferior vena cava filter, the handle and tuohy borst valve separated from the gunther tulip vena cava filter retrieval set's snare, leaving the snare wire exposed.Access was obtained in the right jugular vein, and the device was advanced to the level of the renal veins.Upon snaring the hook of the filter, significant force was applied in opposite directions with the snare and outer sheath to capture the entire filter, as the filter's anchors were embedded.During application of force, the physician inadvertently pulled the handle and tuohy-borst valve off of the snare, leaving the snare wire exposed.Surgical clamps were used to maintain control of the snare wire and contact with the filter hook.The snare system was removed after several unsuccessful attempts to enclose the filter within the sheath.The outer sheath was noted to be kinked and unusable.A loop-snare technique was then attempted to stabilize and capture the filter, utilizing a reverse curve (cook neff) catheter, uniglide exchange wire, 16 french cook performer sheath, and clover snare system.The filter was removed from the patient intact.Additional information was received 04oct2021.The filter had been in place for eight to twelve months.The anatomy was not tortuous or abnormal.Investigation ¿ evaluation a visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, the instructions for use, manufacturing instructions, quality control data, and specifications.The loop system catheter, the blue retrieval sheath, and the loop wire were returned.On the loop system catheter a severe dent was noted in the most distal tip and the clear y-fitting had separated and was not returned.The blue retrieval sheath was severely kinked and damaged with small holes in an accordioned area 95-106mm from the distal tip and another twisted area close to the hub.On the loop wire the loop itself was intact, but several kinks were noted on the loop wire, which had fractured, too, in the proximal end in the transition between handle and loop wire.A review of the device history record found no non-conformances related to the reported failure mode.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: filter retrieval: 16.Hold the retrieval loop steady with the pin vise, then push the y-fitting with the catheter forward, still ensuring that the filter hook is caught in the retrieval loop.Lock the y-fitting to secure the snare around the filter hook.17.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.18.When the tip of the coaxial retrieval sheath is at the filter anchors, loosen the hub of the outer sheath and advance the outer sheath forward to cover the entire filter.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.Based on the investigation findings and the information provided, it is suggested that it fractured when ¿applying opposing forces due to embedded filter anchors¿ and ¿while applying these forces¿ the sheath accordioned, too.Following, when pulling the filter back into the sheath, the anchors of the primary filter legs penetrated the sheath, where accordioned.However, this is only speculation based on the information provided and so it is, if the final filter retrieval with loop-snare technique and a clover snare through the same sheath caused some damages.The instructions for use specify how to properly collapse the filter by advancing the side-arm fitting of the coaxial retrieval sheath (which was not returned) before advancing the outer sheath forward to cover the entire filter for retrieval.Per the quality engineering risk assessment, no further action is warranted.Cook will continue to monitor this device via the complaints database for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or 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: 12513589
• MDR Text Key: 272791537
• Report Number: 1820334-2021-02196
• Device Sequence Number: 1
• Product Code: MMX
• UDI-Device Identifier: 10827002132877
• UDI-Public: (01)10827002132877(17)240629(10)14094572
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/09/2022

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 Expiration Date: 06/29/2024
• Device Catalogue Number: GTRS-200-RB
• Device Lot Number: 14094572
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/08/2021
• Initial Date FDA Received: 09/22/2021
• Supplement Dates Manufacturer Received: 10/04/2021; 11/03/2021; 01/24/2022
• Supplement Dates FDA Received: 10/12/2021; 11/24/2021; 02/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2021
• 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: Female