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 10/21/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The event is currently under investigation.

Event Description

It was reported the inner sheath was separating from the white hub at the proximal end.The device was removed and the procedure completed with a clover snare with no harm to the patient or no further complications.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

Investigation - evaluation: the gunther tulip vena cava filter retrieval set was returned for evaluation (without the snare).A review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, quality control and visual inspection was conducted during the investigation.The instruction for use (ifu) describes the intended use of the device and specifies "that excessive force should not be used to retrieve the filter." visual inspection of the returned device revealed that the black inner sheath was returned inside the blue sheath and that the fitting had separated from the sheath.The sheath flaring was found according to specifications and the cap and luer were properly attached.The sheath tip as well as catheter tip were squeezed and the blue sheath accordioned approximately 18.5 cm from the flaring.The snare was not available for evaluation as it was not returned.There is no evidence to suggest that this device was not manufactured according to specifications.There were no other reported complaints for this lot number.Additional supplier investigation revealed that the risk is recognized and addressed in risk documentation.Per the risk assessment no further action is required as measures have been previously conducted to address this failure mode.Based on these findings it is suggested that the delivery system was exposed to forces beyond its intended strength during the attempted filter retrieval.The device was replaced by a clover snare with no reported injury to the patient.

• 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: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6099014
• MDR Text Key: 59745341
• Report Number: 1820334-2016-01308
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00827002132870
• UDI-Public: (01)00827002132870(17)181231(10)6482649
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2016
• 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: 02/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/29/2015
• 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