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

Model Number G13287

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 01/15/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The ivc filter was reportedly an option elite manufactured by argon.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

It was reported the snare from a gunther tulip vena cava filter retrieval set broke while attempting retrieval of another manufacturer's inferior vena cava filter (ivc) which had been placed (b)(6) 2017.Reportedly, this was the second attempt at retrieving this filter.According to the physician, the complaint snare "broke while it was attached to filter as i was using a twisting motion to try and move the filter away from the vena cava wall".The filter was not removed.It was reported there was no adverse effect to the patient except possibly extended exposure to radiation.No part of the device detached inside the patient.

Manufacturer Narrative

Investigation - evaluation.A review of the complaint history, device history record, manufacturing instructions, quality control, and visual inspection of the returned device was conducted during the investigation.The customer returned the loop wire inside the loop system catheter, as well as a fractured part of the retrieval loop, the y-fitting, the stop cock, and the pin vise.The loop wire and the catheter were curved/bent, maybe to fit into a smaller plastic bag for return.A dent was noted in the distal tip of the catheter, thus indicating that the loop had caught the filter and that attempts had been made to collapse it.The loop had fractured approx.4.5mm and 5.5mm from the cannula and the fractured part was approx.75mm long and exhibited two kinks approximately 17mm and 22mm from one end, respectively.A microscopic investigation of the wires in the loop revealed no sign of any material defect, but found them fractured by twisting/manipulating more than by pulling, which was explained by "using twisting motion to try to move the filter away from the vena cava wall" as reported.Additionally, a document based investigation evaluation was performed.There was no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.The device is shipped with instruction for use (ifu) which notes: "the product has been designed for retrieval of implanted gunther tulip and cook celect vena cava filters in patients who no longer require a filter." the ifu also warns "excessive force should not be used to retrieve the filter." additionally, the argon option elite inferior vena cava filter ifu states: "ix.Optional procedure for filter retrieval - if the filter is retrieved, it should be done within 175 days following implant." moreover, a document based investigation evaluation was performed.There was no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Furthermore, reviews of the manufactures instructions and quality control procedures were conducted, and no gaps were discovered.Based on the information provided and the examination of the returned product, investigation has concluded the cause of this event cannot be traced to the device.The retrieval device was used to retrieve a non - cook filter, but the gtrs has been designed for retrieval of implanted günther tulip and cook celect vena cava filters.The argon filter had been in place for approximately 16 months, which contraindicates retrieval attempts according to argon's labeling.Although no information was provided regarding the handling of this device or patient anatomy., bcause the filter had been in place longer than the retrieval window, it is likely that excessive force/manipulation was required during the retrieval attempt.The cause of this event is likely related to the physician's failure to follow argon's ifu.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment, no further action is required.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 regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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
• MDR Report Key: 8320914
• MDR Text Key: 135539443
• Report Number: 1820334-2019-00331
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00827002132870
• UDI-Public: (01)00827002132870(17)211203(10)9381961
• Combination Product (y/n): N
• PMA/PMN Number: K073374
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/03/2021
• Device Model Number: G13287
• Device Catalogue Number: GTRS-200-RB
• Device Lot Number: 9381961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2019
• Initial Date Manufacturer Received: 01/30/2019
• Initial Date FDA Received: 02/08/2019
• Supplement Dates Manufacturer Received: 05/09/2019
• Supplement Dates FDA Received: 05/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other