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

Model Number G13287

Device Problems Improper or Incorrect Procedure or Method (2017); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/30/2019

Event Type  malfunction  

Manufacturer Narrative

Per the initial reporter, the device will not be returned.Occupation: lead tech.A follow-up report will be submitted should additional relevant information become available.

Event Description

As reported, during retrieval of an unknown inferior vena cava filter, the pin vise separated from a gunther tulip vena cava filter retrieval set snare.The pin vise was tightened and the hook of the filter was snared.The tuohy was tightened and tension was applied.As the physician began to retrieve the filter "everything started to float" as the pin vise separated and the snare went into the sheath.All connections were loosened and the user pulled back on the snare catheter until the snare wire was visualized, at which time the wire was clamped and the entire device, along with the filter, was removed from the patient successfully.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Event summary: as reported, during retrieval of an unknown inferior vena cava filter, the pin vise separated from a gunther tulip vena cava filter retrieval set snare.The pin vise was tightened and the hook of the filter was snared.The tuohy was tightened and tension was applied.As the physician began to retrieve the filter "everything started to float" as the pin vise separated and the snare went into the sheath.All connections were loosened and the user pulled back on the snare catheter until the snare wire was visualized, at which time the wire was clamped and the entire device, along with the filter, was removed from the patient successfully.Investigation - evaluation.Reviews of the complaint history, device history record, documentation, instructions for use, manufacturing instructions, and specifications of the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document-based investigation evaluation was conducted.A review of the device history record shows one nonconforming event which could have contributed to this failure mode.The affected product was subsequently scrapped.It should be noted there were no other reported complaints for this lot number.Reviews of specifications and manufacturing instructions were also conducted, and no gaps were discovered.The available information provides objective evidence to support that the device was manufactured to specification.The device is packaged with instructions for use, which warn that excessive force should not be used to retrieve the filter.Based on the information provided, investigation has concluded that, while a definitive cause for the device failure could not be established, the pin vise separation may have been loosened or may have been pulled with excessive force during filter retrieval, as warned against in the instructions for use.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 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: 9172686
• MDR Text Key: 161732841
• Report Number: 1820334-2019-02559
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00827002132870
• UDI-Public: (01)00827002132870(17)220327(10)9658431
• 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: 04/10/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 03/27/2022
• Device Model Number: G13287
• Device Catalogue Number: GTRS-200-RB
• Device Lot Number: 9658431
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/30/2019
• Initial Date FDA Received: 10/09/2019
• Supplement Dates Manufacturer Received: 04/01/2020
• Supplement Dates FDA Received: 04/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1