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

Model Number	G13287
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported, the physician could not get the "small sheath" over the top of a filter (manufacturer not specified).In the process, the "torque device" broke off a gunther tulip vena cava filter retrieval set catheter.The filter was successfully removed using the outer sheath.No patient adverse effects were reported.Although requested, no information has been received regarding event details, the filter manufacturer, or how long it was in place.
Additional Manufacturer Narrative
Investigation - evaluation.Reviews of the complaint history, device history record, instructions for use, manufacturing instructions, quality control, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that only the pin vise was returned.Components of the pin vise were easily re-assembled and mounted on a test loop wire and even with a reasonable amount of pulling, it could not be removed.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, reviews of the manufacturer¿s instructions and quality control procedures were conducted, and no gaps were discovered.The instructions for use (ifu) included with the product states: ¿loosen the screw of the clear y-fitting to enable advancement of the loop inside the catheter.Hold the clear y-fitting and advance the pin vise.Advance until the loop has fully expanded inside the vena cava and surrounds the filter.Pull back the loop until it engages the hook of the filter.Hold the wire loop steady with the pin vise, then push the clear y-fitting with the catheter forward until it touches the hook.Lock the clear y-fitting to secure the snare around the filter hook.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.¿ based on the information provided and the examination of the returned product, investigation has concluded that a definitive root cause of the event cannot be determined, but may be traced to the user and unintended use error.It is possible that the pin vise may have been loosened during attempts to advance the retrieval catheter to collapse the filter.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 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.
Event or Problem 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
• Common Device Name: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8426138
• Report Number: 1820334-2019-00608
• Device Sequence Number: 16590594
• Product Code: DTK
• UDI-Device Identifier: 00827002132870
• UDI-Public: (01)00827002132870(17)220107(10)9451691
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K073374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/07/2022
• Device Model Number: G13287
• Device Catalogue Number: GTRS-200-RB
• Device Lot Number: 9451691
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2019
• Initial Date Received by Manufacturer: 03/01/2019
• Supplement Date Received by Manufacturer: 01/08/2020
• Initial Report FDA Received Date: 03/15/2019
• Supplement Report FDA Received Date: 01/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1