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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
Event Type  Injury  
Event Description

Information was provided to the manufacturer on (b)(6) 2011: the filter was placed on (b)(6) 2010. Physician felt the landing was picture perfect, straight up and down in the vena cava with no tilt. The patient started having pains and imaging revealed that the filter legs were protruding through the inferior vena cava. On (b)(6) 2011, the physician tried to remove the filter in cath lab with a cook retrieval kit; however, he was unable to do so because the hook had tilted into the left renal vein. He decided to bring the patient back to the operating room under sedation. So, on (b)(6) 2011, he attempted to remove filter again with a cook retrieval kit. The case did not go well, issues snaring and retrieving it. Eventually part of the snare broke off and floated up into the right pulmonary middle lobe. At this point the procedure was aborted and the foreign body was retrieved with a snare. This caused rapid ventricular rate but the patient still had stable blood pressure. After second procedure there was no evidence of extravasation. The physician has consulted a colleague and another physician will be performing in open procedure to remove the filter. Update received (b)(6) 2011: the patient had her filter removed via open procedure and she is doing well. Patient is scheduled to go home (b)(6) 2011.

 
Manufacturer Narrative

Expiration date unknown as lot is unknown. (b)(4). Separates is not labeled. Very limited information provided regarding this event. No product or images received for investigation and without the actual complaint device the exact reason for the difficulties encountered cannot be determined. Lot unknown; therefore, manufacturing records cannot be inspected. The product is shipped with an ifu; which contains the following warning, "excessive force should not be used to retrieve the filter. " this retrieval set is inspected and tensile strength tested according to quality control instruction. The product is shipped with an ifu; which contains the following warning, "excessive force should not be used to retrieve the filter. " we will continue to monitor for similar complaints and have notified the appropriate personnel. Quality engineering risk assessment was not updated in response to this complaint. The addition of this complaint would not increase the risk priority number, therefore, the conclusion of qera that no further mitigating action is necessary, is still valid at this time.

 
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Brand NameGUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section F)
COOK, INC.
bloomington IN 47404
Manufacturer (Section D)
COOK, INC.
bloomington IN 47404
Manufacturer Contact
rita harden, manager
750 daniels way
bloomington , IN 47404
(812) 339 -2235
Device Event Key2333194
MDR Report Key2309907
Event Key2206803
Report Number1820334-2011-00637
Device Sequence Number1
Product CodeDTK
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 09/22/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/20/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberGTRS-200-RB
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Device Age na
Event Location Hospital
Was The Report Sent To Manufacturer? No
Date Manufacturer Received10/19/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 10/20/2011 Patient Sequence Number: 1
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