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

Model Number N/A

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/08/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has been requested and not yet received.The event is currently under investigation.

Event Description

It was reported that during an ivc filter removal procedure using a gunther tulip vena cava filter retrieval set, in two separate procedures on the same day, the pin device disconnected from the end of the snare and then the luer lock on the 11 fr sheath separated from the sheath as the physician was pulling.The filters were successfully removed with no adverse effects to the patients.

Manufacturer Narrative

Investigation - evaluation: a review of the complaint history, device history record, manufacturing instructions, quality control, and visual inspection of the returned device was conducted for this investigation.An investigation of the returned device found the loop wire and its protecting sheath severely damaged in the handle end, but the pin vise was still attached.Approximately 10mm of the blue sheath was compressed approximately 5cm from the tip and the hub was missing.The flare measured to be within specifications.Based on these findings and the information provided, the exact reason for the pin vise to disconnect from the loop wire, cannot be determined, nor can the reason for the hub to separate from the sheath, but it is suggested that the components were exposed to manipulation beyond their intended design during the filter retrieval.It is noted that the filter was successfully removed with no adverse effects to the patient.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.We will continue to monitor for similar complaints, and have notified the appropriate personnel of this event.

• 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
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6614296
• MDR Text Key: 76740194
• Report Number: 1820334-2017-01089
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00827002132870
• UDI-Public: (01)00827002132870(17)200331(10)7790804
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/21/2017

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 Model Number: N/A
• Device Catalogue Number: GTRS-200-RB
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/08/2017
• Initial Date FDA Received: 06/06/2017
• Supplement Dates Manufacturer Received: 09/14/2017
• Supplement Dates FDA Received: 09/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1