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

Model Number G13287

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/29/2019

Event Type  malfunction  

Manufacturer Narrative

A follow-up report will be submitted should additional relevant information become available.

Event Description

As reported, during a procedure to retrieve a gunther tulip filter that had been in place for four months, involving a (b)(6) year-old female patient, a gunther tulip vena cava filter retrieval set snare separated.Reportedly, the "rod that goes in an out was broken," and upon pulling the device back, it "popped".The device was removed in its entirety from the patient.The user then tried to "push it back in" and the physician pulled the pin vise back, at which point the rod "snapped off" approximately ten centimeters from the pin vise.Another cook snare was used to complete the procedure.Reportedly, the user followed the instructions for use and excessive force was not required.The patient's anatomy was not unusual considering the procedure.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 additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Summary of event: as reported, during a procedure to retrieve a gunther tulip filter that had been in place for four months, involving a 66 year-old female patient, a gunther tulip vena cava filter retrieval set snare separated.Reportedly, the "rod that goes in an out was broken," and upon pulling the device back, it "popped".The device was removed in its entirety from the patient.The user then tried to "push it back in" and the physician pulled the pin vise back, at which point the rod "snapped off" approximately ten centimeters from the pin vise.Another cook snare was used to complete the procedure.Reportedly, the user followed the instructions for use and excessive force was not required.The patient's anatomy was not unusual considering the procedure.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: a review of the complaint history, device history record, documentation, quality control, and visual inspection of the complaint device was conducted during the investigation.The loop wire and the loop system catheter with y-fitting were returned to cook for investigation.A minor kink was noted in the catheter 19mm from the hub and almost the whole loop wire was pulled backwards and exiting from the y-fitting.The loop wire had fractured next to the soldering between loop wire and handle/cannula approximately 10cm from the pin vise.During investigation, approximately 20cm of the catheter was cut off to advance the loop wire and make it visible for investigation, and no damages were noted on the loop itself.A detailed microscopic investigation of the fracture found no material defects and revealed that the loop wire did not fracture in one movement but had been exposed to various forces: the fractured material was squeezed and the outer diameter was affected, thus suggesting the loop wire had been bent back and forth.The squeezed material was elongated and small, circular marks indicated that pulling and twisting following the bending resulted in the fracture.A document-based investigation evaluation was performed.No related non-conformances were found, and there have been no other reported complaints for this lot number.The information provided upon review of complaint file, device history record, complaint history, device master record, and design validation testing provide objective evidence to support that the device was manufactured to specification.As 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 the field.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The product ifu warns against use of excessive force during filter retrieval.Based on the information provided and the results of the investigation, cook has concluded that while a definitive conclusion could not be determined, based on the condition of the returned device it is suggested that the loop had been firmly attached to an object and that strong manipulation to free it caused damages and weakened the loop wire, making it difficult to push it back as reported.Consequently, the reported pulling of the pin vise resulted in the loop wire to fracture where weakened, after it was retrieved from the patient.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.

• 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: 8855050
• MDR Text Key: 153840269
• Report Number: 1820334-2019-01915
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00827002132870
• UDI-Public: (01)00827002132870(17)220410(10)9692668
• 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: 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/10/2022
• Device Model Number: G13287
• Device Catalogue Number: GTRS-200-RB
• Device Lot Number: 9692668
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2019
• Date Manufacturer Received: 07/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR