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

Model Number G13287

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/15/2019

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 patient of unknown gender or age was undergoing removal of a celect platinum filter (cook) which had been implanted less than six months.During the retrieval, the tip of the sheath included in the gunther tulip vena cava filter retrieval set, appeared split about an inch at the distal tip.One of the primary legs of the filter appeared to be through the sheath.The procedure was completed with the use of this device.No additional procedures were required and no patient adverse effects were reported.

Manufacturer Narrative

Investigation ¿ evaluation.Reviews of the complaint history, device history record, manufacturer¿s instructions, quality control procedures, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned package confirmed that only the blue retrieval sheath was returned with the red inner catheter placed inside.Both components had several kinks in matching areas ¿ some of the kinks may have been caused by the return shipping of the device.On the sheath an approximately 3.5cm split was noted at the most distal tip, as if penetrated by a primary filter leg, as reported.Additionally, a document-based investigation evaluation was performed.The evidence indicates the product was made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should also be noted there were no other reported complaints for this lot number.Furthermore, reviews of the manufacturer¿s instructions and quality control procedures were conducted, and no gaps were discovered.An ifu is provided with this device, which states ¿while holding the retrieval loop and clear y-fitting steady, advance the white tuohy-borst side-arm adapter with the coaxial retrieval system.The filter collapses and the hooks disengage from the caval wall.¿ the ifu goes on to note ¿when the tip of the coaxial retrieval system is at the barbed hooks, loosen the hub of the blue outer sheath, advance the outer sheath forward to cover the whole filter, and retrieve the complete assembly.¿ and finally, the ifu warns that ¿excessive force should not be used to retrieve the filter.¿ since it is reported that "one of the primary legs appeared to be through the sheath", it is suggested that the filter was not properly collapsed prior to advancing the outer sheath.The instructions for use caution that the coaxial retrieval system must be advanced to collapse the filter prior to advancing the outer sheath.This complaint will be confirm based on customer testimony and inspection of device.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.

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: 8457236
• MDR Text Key: 140166292
• Report Number: 1820334-2019-00695
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00827002132870
• UDI-Public: (01)00827002132870(17)211210(10)9392410
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 03/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/10/2021
• Device Model Number: G13287
• Device Catalogue Number: GTRS-200-RB
• Device Lot Number: 9392410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2019
• Date Manufacturer Received: 03/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1