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 10/03/2018

Event Type  malfunction  

Manufacturer Narrative

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, a male patient approximately in his 50's, underwent an inferior vena cava (ivc) filter retrieval procedure where a gunther tulip vena cava filter retrieval set was used.Access was gained using a micropuncture set.A guidewire was inserted into the ivc and a flush catheter was inserted.A venogram was performed, the complaint device inserted over the wire and the filter was snared.While retracting the filter into the 9fr inner sheath using mild force, the outer 11fr sheath partially separated.Nothing detached in the patient.The physician was able to remove the entire system with the filter from the patient's anatomy.A section of the device did not remain inside the patient¿s body.There was no harm to the patient and no need for any additional procedures.The filter had been in place approximately two years.No other devices were used during the removal of the cook tulip ivc filter.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Investigation ¿ evaluation.A review of the dimensional verification, complaint history, device history record, instructions for use (ifu), manufactures instructions, quality control, specifications, and a functional test & visual inspection of the returned device was conducted during the investigation.The visual inspection of the returned device confirmed that the blue and black sheaths were returned and could be investigated.The blue sheath was separated from the hub fitting.The flare of the blue sheath was measured to 7.2mm, which was within specification.A new hub fitting was screwed on to the returned blue sheath and using a reasonable amount of force, the fitting could not be pulled off the sheath.Additionally, a document based investigation evaluation was performed.There is 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, an ifu is provided with the device, which states ¿excessive force should not be used to retrieve the filter.¿ based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could be traced to the user and unintended use error.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.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.

• 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: 7992385
• MDR Text Key: 126229190
• Report Number: 1820334-2018-03153
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00827002132870
• UDI-Public: (01)00827002132870(17)210702(10)9036519
• 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: 01/22/2019

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: 07/02/2021
• Device Model Number: G13287
• Device Catalogue Number: GTRS-200-RB
• Device Lot Number: 9036519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2018
• Initial Date Manufacturer Received: 10/05/2018
• Initial Date FDA Received: 10/22/2018
• Supplement Dates Manufacturer Received: 01/21/2019
• Supplement Dates FDA Received: 01/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1