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

Model Number G13287

Device Problem Kinked (1339)

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

Event Date 04/14/2016

Event Type  malfunction  

Manufacturer Narrative

This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.

Event Description

It was reported that during a filter retrieval procedure for a filter placed in (b)(6) 2016, the outer 11 fr blue sheath kinked on the distal end 1 to 2 cm above the black radiopaque marker.This caused difficulty pushing forward; however, the doctor did get it to go.It was noted that when the sheath was removed, a kink was visible.No pieces of the device remained inside the patient's body, and there were no injuries or additional medical intervention reported.

• 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 ; 8128294891
• MDR Report Key: 6741078
• MDR Text Key: 81142073
• Report Number: 1820334-2017-02148
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00827002132870
• UDI-Public: (01)00827002132870(17)181130(10)6434117
• 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: Other
• Type of Report: Initial
• Report Date: 07/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G13287
• Device Catalogue Number: GTRS-200-RB
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2015
• 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