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

Catalog Number GTRS-200-RB

Device Problem Material Separation (1562)

Patient Problem No Code Available (3191)

Event Date 11/08/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that during an inferior vena cava (ivc) filter retrieval, the end of the gunther tulip vena cava filter retrieval device broke off.All pieces of the gunther tulip vena cava filter retrieval set were able to be removed.Additional information pertaining to the exact piece of the retrieval device broken off was requested, but is not available per the initial reporter.The ivc filter was unable to be retrieved, and the patient was scheduled to return for another attempt at filter removal.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, device history record, documentation, instructions for use (ifu), manufacturing instructions, specifications, quality control, and visual inspection of the returned device was conducted during the investigation.The gunther tulip vena cava filter retrieval set pin vise was returned, but not the retrieval device itself.The pin vise was found untightened, and thus would not be able to lock to a loop wire/ handle in the returned state.However, during investigation the pin vise was able to be locked and functioned as intended.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Numerous design verification and validation activities have been performed to ensure that this device meets design requirements.Review of the device history record of the finished product shows no nonconforming events that could contribute to this failure mode.A complaint history search revealed that there were no other reported complaints for this lot number.The gunther tulip vena cava filter retrieval set is used for the retrieval of implanted günther tulip and cook celect vena cava filters in patients who no longer require a filter.Retrieval of the filter can be performed only by a jugular approach.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, a definite root cause could not be determined; however, it is likely that this event can be attributed to user technique.Per the risk assessment, no further action is required.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
• MDR Report Key: 7046787
• MDR Text Key: 92586103
• Report Number: 1820334-2017-04210
• Device Sequence Number: 1
• Product Code: DTK
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 02/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: GTRS-200-RB
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR