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

Catalog Number GTRS-200-RB

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This event is under investigation.

Event Description

During a filter retrieval procedure, the loop of the gunther tulip vena cava filter retrieval snare broke when trying to remove the filter.Another device was used to complete the procedure.The patient remained unharmed, no fragments were within the patient.No additional details have been received.

Manufacturer Narrative

A review of the following: review of complaint history, review of instructions for use (ifu), review of specifications, visual inspection.Only the retrieval hook portion of the device was returned for evaluation.Visual inspection noted the loop to be fractured in the middle of its "nose".The wires had a slightly unraveled appearance with no indication that the fractured surfaces experienced inclusion of any of the wires.There is no evidence to suggest the product was not made to specifications.Per the ifu: excessive force should not be used to retrieve the filter.Based on the information provided and results of the investigation it is feasible that the device was exposed to high forces during manipulation and attempts to retrieve the filter resulting in fracture of the loop wires; however, a definitive root cause to the reported event could not conclusively be determined.Per the risk assessment no further action is required.We will continue to monitor for similar complaints.

• 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: 6356365
• MDR Text Key: 68280983
• Report Number: 1820334-2017-00269
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073374
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: GTRS-200-RB
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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