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

Model Number G13287

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2019

Event Type  malfunction  

Manufacturer Narrative

Occupation = lead tech.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

As reported, during a filter removal procedure using jugular access, the hub of the gunther tulip vena cava filter retrieval set separated.According to the initial reporter, the physician snared the filter and while he was advancing the sheath over the filter, he began to remove the coaxial system.The hub then separated from the outer sheath.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.

Event Description

No additional patient/event details have been received since the previous medwatch report was sent.

Manufacturer Narrative

Investigation - evaluation.On (b)(6) 2019, cook was informed of an incident where, during a procedure, the hub of a gunther tulip vena cava filter retrieval set (rpn: gtrs-200-rb; lot: 9850582) separated from the sheath.The issue was reported by a physician at azh vascular center in milwaukee, wi.No adverse effects to the patient were reported and the filter was successfully retrieved.A review of documentation including the complaint history, device history record (dhr), and manufacturing instructions (mi), as well as a visual inspection of the returned device was conducted during the investigation.A loop system catheter, retrieval sheath, retrieval catheter, pin vise, and stop cock were returned to cook for evaluation.Upon visual inspection, the retrieval sheath was found to have a squeeze mark and two kinks.Additionally, the sheath was separated from the hub.The flare of the sheath had some visibly notable marks.A new hub was mounted to the sheath and was unable to be separated.Components were also measured and found to be within tolerance, indicating that the device was manufactured to specification.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the dhrs for the reported complaint device lot (9850582) and the related component/sub-assembly lots revealed no recorded non-conformances.A database search did not identify any other events associated with the reported device lot.Furthermore, cook has concluded that there is no evidence suggesting that non-conforming product exists either in house or in field.As the coaxial retrieval sheath system is provided to cook from an external manufacturer, a supplier investigation was conducted.Findings of the supplier investigation were consistent with those of cook inc.Cook also reviewed product labeling.This device is shipped with instructions for use t_tulret_rev0 which includes the following information relevant to the event: warning states: ¿excessive force should not be used to retrieve the filter.¿ instruction for use states: ¿11.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.¿ based on the information provided, inspection of the returned product, and the results of our investigation, a root cause was traced to unintended user error.The likely cause for the reported event is potential use of excessive force, which led to the separation of the hub from the sheath.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.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.

• 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: 9495581
• MDR Text Key: 175903348
• Report Number: 1820334-2019-03153
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00827002132870
• UDI-Public: (01)00827002132870(17)220613(10)9850582
• 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: 04/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/13/2022
• Device Model Number: G13287
• Device Catalogue Number: GTRS-200-RB
• Device Lot Number: 9850582
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2020
• Date Manufacturer Received: 04/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SAFE-T-J WIRE.035 180 CM
• Patient Age: 44 YR