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 Known Impact Or Consequence To Patient (2692)

Event Date 02/08/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The reported device has been requested; the event is currently under investigation.

Event Description

It was reported that during a filter retrieval procedure, the outer sheath of the gunther tulip vena cava filter retrieval set separated from the hub while advancing the inner and outer sheaths together.It was reported that the filter was successfully retrieved without any additional interventions.There have been no adverse effects to the patient reported.

Manufacturer Narrative

A review of the complaint history, instructions for use (ifu), specifications, and visual inspection of the returned device was conducted during the investigation.The black inner catheter and blue sheath were returned for evaluation.Visual inspection revealed that the hub was separated at the proximal end of the sheath.The sheath flaring was according to specifications.A testing fitting was attached to the sheath and was impossible to be removed by pulling.The cap attachment to the two fittings appeared the same.The black sheath and blue sheaths were noted to be severely kinked.Two minor kinks were noted at approximately 15 millimeters (mm) and 6 centimeters (cm) from the flaring.A document based investigation evaluation was also performed.There is no evidence to suggest the product was not made to specifications.The lot number of the device is not known; accordingly a review of the device history record could not be conducted.Per the ifu: "excessive force should not be used to retrieve the filter." evaluation of the sheaths indicate that they may have been exposed to excessive force during manipulation.Based on the information provided and results of the investigation the most likely root cause of the reported event may be related to excessive force during product use/ handling.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: 6396008
• MDR Text Key: 69854795
• Report Number: 1820334-2017-00362
• 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: 07/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2017
• 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
• Date Manufacturer Received: 06/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1