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

Catalog Number GTRS-200-RB

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 07/12/2021

Event Type  malfunction  

Manufacturer Narrative

Occupation = lead tech.Pma/510(k) number = k181757.A follow-up report will be submitted should additional relevant information become available.

Event Description

As reported, during retrieval of an unspecified gunther tulip inferior vena cava filter that was placed in (b)(6) 2021, the sheath included in a gunther tulip vena cava filter retrieval set split.An initial venogram was performed prior to retrieval of the filter.Minor tortuosity was noted.When the filter was snared, the user discovered that part of a secondary filter strut was bent upwards and was no longer attached to a primary strut.The snare became stuck on the secondary strut and was unable to be released, so the snare was then advanced over the filter hook.The filter and secondary strut were snared; however, as the user attempted to advance the sheath over the filter, the secondary strut "sheared" the inside of the retrieval sheath, causing it to tear.This was visualized under fluoroscopy.The user released the snare from the filter and strut and advanced a wire guide to maintain access.The sheath was then removed and another unknown 10 french sheath was used to retrieve the filter via the same access site.All pieces of the filter were retrieved successfully.A photo of the sheath, provided by the customer, shows that the distal end of the sheath was split.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

No new patient or event information to report.

Manufacturer Narrative

Description of event: as reported, during retrieval of an unspecified gunther tulip inferior vena cava filter that was placed in (b)(6) 2021, the sheath included in a gunther tulip vena cava filter retrieval set split.An initial venogram was performed prior to retrieval of the filter.Minor tortuosity was noted.When the filter was snared, the user discovered that part of a secondary filter strut was bent upwards and was no longer attached to a primary strut.The snare became stuck on the secondary strut and was unable to be released, so the snare was then advanced over the filter hook.The filter and secondary strut were snared; however, as the user attempted to advance the sheath over the filter, the secondary strut "sheared" the inside of the retrieval sheath, causing it to tear.This was visualized under fluoroscopy.The user released the snare from the filter and strut and advanced a wire guide to maintain access.The sheath was then removed and another unknown 10 french sheath was used to retrieve the filter via the same access site.All pieces of the filter were retrieved successfully.A photo of the sheath, provided by the customer, shows that the distal end of the sheath was split.Investigation ¿ evaluation: a document based investigation was performed including a review of complaint history, device history record, quality control data, and specifications.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.There is no evidence to suggest the product was made out of specification.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: 10.While holding the retrieval loop and clear y-fitting steady, advance the white tuohy-borst side-arm adapter with the coaxial retrieval system.The filter collapses and the hooks disengage from the caval wall.11.When the tip of the coaxial retrieval system is at the barbed hooks, loosen the hub of the blue outer sheath, advance the outer sheath forward to cover the whole filter, and retrieve the complete assembly.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.Ideally, the filter should be entirely collapsed within the inner portion of the sheath and retracted as a unit through the outer portion of the blue sheath with little to no portion of the filter coming into contact with the blue sheath.This latter complication involving the outer/blue sheath is a direct result of the first complication which is fracture and displacement of the secondary filter arm.It is therefore concluded that unintended user error has caused or contributed to this failure.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: kailey medfisch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 12214511
• MDR Text Key: 263461664
• Report Number: 1820334-2021-01855
• Device Sequence Number: 1
• Product Code: MMX
• UDI-Device Identifier: 10827002132877
• UDI-Public: (01)10827002132877(17)220828(10)10012453
• 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
• Report Date: 12/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2022
• Device Catalogue Number: GTRS-200-RB
• Device Lot Number: 10012453
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2019
• 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: 59 YR
• Patient Sex: Male
• Patient Race: White