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U.S. Department of Health and Human Services

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

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COOK INC GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number GTRS-200-RB
Device Problem Material Separation (1562)
Patient Problem No Code Available (3191)
Event Date 08/22/2008
Event Type  Injury  
Manufacturer Narrative

Date aware, within the medical record, it is additionally stated that a ¿representative from the cook medical device company was notified of this event,¿ on 22aug2008, though this contact was unable to be substantiated by any further records or information available to cook. It is unknown if the device will be returned. Occupation = non-healthcare professional. (b)(4). This report includes information known at this time. A follow-up report will be submitted should additional relevant information become available.

 
Event Description

As reported via short form complaint, during attempted retrieval of an inferior vena cava filter on (b)(6) 2008, a gunther tulip vena cava filter retrieval set snare separated approximately two centimeters above the loop. As stated in medical records provided as part of the short form complaint, the filter was originally placed on (b)(6) 2008 for multisystem trauma, internal injuries, and contraindications to anticoagulation. At the time of filter removal, the patient was stable on lovenox and removal of the filter was deemed appropriate. Local anesthesia and sedation were given for the procedure. The right internal jugular vein was cannulated, and an unknown wire and sheath were advanced to the location of the filter. A venogram was performed, showing no clot within the filter. An unknown snare catheter was used to attempt removal but was unsuccessful. Imaging showed the hook of the filter abutting the anterior wall of the vessel. An unknown pigtail catheter was used to try to loosen the filter; however, this was also unsuccessful. The complaint device was then used for attempted filter removal. The catheter snared one of the filter barbs and was reportedly difficult to dislodge, resulting in separation of the snare. The separated portion was free-floating within the vena cava and was retrieved with an unknown three-looped snare catheter. Additional attempts were made to remove the filter with unknown three-loop snare catheters and another gunther tulip snare; although, these attempts were also unsuccessful (see medwatch #3002808486-2020-00138). A venogram then showed the filter in good position with no signs of injury to the vena cava. The filter was left in place and the patient was reportedly stable throughout the procedure. There has been no report that any part of the complaint device was left in the patient or that the patient experienced any adverse effects due to separation of the snare.

 
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Brand NameGUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer (Section G)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
jennifer canada
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key9788162
MDR Text Key189767138
Report Number1820334-2020-00545
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK073374
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 03/04/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/04/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberGTRS-200-RB
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/24/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 03/04/2020 Patient Sequence Number: 1
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