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 10/04/2019

Event Type  malfunction  

Manufacturer Narrative

Occupation: non-healthcare professional, sourcing specialist.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 flush valve of the outer sheath included in the gunther tulip vena cava filter retrieval set detached from the sheath.The procedure was completed and the filter was retrieved successfully, despite the separation of the valve.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

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Correction: h6 device code.Summary of event: as reported, during retrieval of an unknown inferior vena cava filter, the flush valve of the outer sheath included in the gunther tulip vena cava filter retrieval set detached from the sheath.The procedure was completed, and the filter was retrieved successfully, despite the separation of the valve.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.Investigation evaluation.A review of the complaint history, device history record, documentation, and manufacturing instructions was conducted during the investigation.The complaint device was not returned and no photos were provided; therefore, inspection of the device was not possible.A document-based investigation evaluation was performed.A review of the device history record revealed no failure related nonconformances.A complaint search revealed no other complaints associated with this lot number.The device history file was reviewed, and risk controls are in place for this failure mode.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The information provided upon review of the complaint file provides evidence to support that the device was manufactured to specification, as there are adequate inspection activities established and objective evidence that the dhr was fully executed.It was also concluded that there is no evidence that nonconforming product exists in house or in the field.The device is packaged with instructions for use, which warn the user against use of excessive force during filter retrieval.Investigation has concluded that based on the information provided, a definitive root cause for this event cannot be determined; however, use of excessive force is possible.It should be noted that information regarding the filter type and dwell time was not provided, and the ifu warns that excessive force should not be used to retrieve the filter.Per the quality engineering risk assessment, no further action is required.Cook will continue to monitor for similar complaints.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: 9272486
• MDR Text Key: 165115373
• Report Number: 1820334-2019-02762
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00827002132870
• UDI-Public: (01)00827002132870(17)220520(10)9793337
• 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: 04/07/2020

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: 05/20/2022
• Device Model Number: G13287
• Device Catalogue Number: GTRS-200-RB
• Device Lot Number: 9793337
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/29/2019
• Initial Date FDA Received: 11/04/2019
• Supplement Dates Manufacturer Received: 04/03/2020
• Supplement Dates FDA Received: 04/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1