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 Known Impact Or Consequence To Patient (2692)

Event Date 10/29/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.

Event Description

During an inferior vena cava (ivc) filter removal, in which the ivc filter was able to be hooked and the retrieval had begun, the gunther tulip vena cava filter retrieval set filter retrieval wire snapped after back tension was applied.The filter retrieval wire was able to be removed, and a new device was utilized to retrieve the ivc filter.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Investigation - evaluation: a review of the complaint history, dimensional verification, device history record, instructions for use (ifu), manufacturing instructions, trends, quality control, functional testing, and visual inspection of the returned device was conducted during the investigation.The black inner catheter with the loop wire inside was returned.The loop wire had separated in the handle end in the transition between handle and shaft and both parts were severely damaged/curled.No damages were noted on the transition itself.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events.There were no other reported complaints for this lot number.Per the ifu, "excessive force should not be used to retrieve the filter." based on the information provided, examination of the returned product, and the results of our investigation; the exact reason for the separation cannot be determined.However, based on the curled portion of the device and because "back tension was applied", it is likely that cause was excessive force during the unsuccessful retrieval attempt.Per the risk assessment, no further action is required.Appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.

• 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 Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 7033325
• MDR Text Key: 93003655
• Report Number: 1820334-2017-03744
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00827002132870
• UDI-Public: (01)00827002132870(17)200730(10)8123010
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073374
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/29/2018

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 Model Number: G13287
• Device Catalogue Number: GTRS-200-RB
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/30/2017
• Initial Date FDA Received: 11/15/2017
• Supplement Dates Manufacturer Received: 01/29/2018
• Supplement Dates FDA Received: 01/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2017
• 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: 83 YR