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

Catalog Number GTRS-200-RB

Device Problem Wire(s), breakage of (2347)

Patient Problem Foreign body, removal of (2365)

Event Date 02/20/2014

Event Type  Injury  

Event Description

After accessing jugular vein, the physician attempted to retrieve the ivc filter.The physician fully expanded the snare loop on the gunther tulip vena cava filter retrieval set; however, did not like positioning and attempted to retract the snare loop.As the physician pulled "pin-vice" back, the snare loop broke free from the catheter.The snare loop remained in the patient until the physician accessed via femoral vein and retrieved the cook snare loop with an ensnare.After the broke snare loop was removed from the patient, a new retrieval set was used to perform a traditional ivc filter removal via juglar vein.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Event evaluation: still under investigation.

• Brand Name: GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): COOK, INC.; bloomington IN 47404
• Manufacturer Contact: rita harden, director ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 3713453
• MDR Text Key: 4265589
• Report Number: 1820334-2014-00106
• 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: Unknown
• Type of Report: Initial
• Report Date: 02/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Catalogue Number: GTRS-200-RB
• Device Lot Number: 4439637
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/10/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/20/2014
• Device Age: 6 MO
• Event Location: Hospital
• Date Manufacturer Received: 02/24/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/08/2013
• 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
• Patient Outcome(s): Required Intervention