MAUDE Adverse Event Report: COOK INC GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number GTRS-200-RB

Device Problems Crack (1135); Fracture (1260); Component Missing (2306)

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

Event Date 04/19/2021

Event Type  malfunction  

Manufacturer Narrative

Date of birth: (b)(6).Report occupation: other non-healthcare professional: manager.Pma/510k #: exempt.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 a filter retrieval procedure the gunther tulip vena cava filter retrieval set appeared to have a missing component meant to manipulate the snare (patient reference (b)(6)).They kept the blue sheath from the first set and were able to advance another snare through the original sheath.When they went to remove the filter after the capture, they noted the blue sheath "completely shivered up" (patient reference (b)(6)).No unintended section of the device remained inside of the patient's body.No additional procedures were required due to the occurrence.No adverse effects were reported due to the occurrence.

Manufacturer Narrative

Additional information: b5, h6- the two devices referenced in this report were used in the same event and have the same product lot.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

Two devices were returned for investigation.The blue sheath of the device originally reported as having "shivered up" had a 43mm crack in the distal tip, and the loop wire was fractured in the proximal end.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Description of event: as reported, during a filter retrieval procedure the gunther tulip vena cava filter retrieval set appeared to have a missing component meant to manipulate the snare (patient reference (b)(4)).They kept the blue sheath from the first set and were able to advance another snare through the original sheath.When they went to remove the filter after the capture, they noted the blue sheath "completely shivered up" (patient reference 329028).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, documentation, the instructions for use, quality control data, and specifications.The retrieval loop system inside the retrieval sheath system was returned.The pin vise was not returned and is considered the component reportedly missing.Indentations were noted in the distal tip of the blue sheath, as if damaged during attempts to collapse something or pull something back.The retrieval loop system had several kinks, one of them close to the y-fitting, but the loop itself was intact and without any damage.During investigation another pin vise was attached and worked as intended.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.A complaints database search found two other complaints associated with the complaint lot reported under patient identifiers 329028 and 344259.All three events occurred during the same procedure.It was assessed that because no non-conformances were detected, there is evidence that the dhr was fully executed.It is therefore 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: the product has been designed for retrieval of implanted günther tulip and cook celect vena cava filters in patients who no longer require a 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 these findings the exact reason for the pin vise to separate cannot be determined, but it is noted that attempts were made to retrieve a non-cook filter and according to the instructions for use the gtrs device has been designed for retrieval of implanted günther tulip and cook celect vena cava filters in patients who no longer require a filter.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.

Event Description

No new patient or event information to report.

• Brand Name: GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• 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: 11768596
• MDR Text Key: 265016724
• Report Number: 1820334-2021-01274
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002132877
• UDI-Public: (01)10827002132877(17)240228(10)13778059
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/29/2021

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: 02/28/2024
• Device Catalogue Number: GTRS-200-RB
• Device Lot Number: 13778059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/20/2021
• Initial Date FDA Received: 05/04/2021
• Supplement Dates Manufacturer Received: 05/17/2021; 11/04/2021
• Supplement Dates FDA Received: 10/20/2021; 11/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2021
• 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