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U.S. Department of Health and Human Services

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

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COOK INC GUNTHER TULIP FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-FEM
Device Problems Migration or Expulsion of Device (1395); Unintended Movement (3026); Insufficient Information (3190)
Patient Problems Perforation of Vessels (2135); Blood Loss (2597); No Information (3190)
Event Date 12/08/2014
Event Type  Injury  
Manufacturer Narrative
Additional information provided determined that this device was manufactured by cook inc. With the submission of this follow up report, william cook europe informs that this complaint has been transferred from william cook europe to cook inc.
 
Event Description
Additional information provided determined that this device was manufactured by cook inc. With the submission of this follow up report, william cook europe informs that this complaint has been transferred from william cook europe to cook inc.
 
Manufacturer Narrative
(b)(4). Catalog is unknown but referred to as cook gunther tulip filter. Implant: (b)(6) 2011. (b)(4). Investigation is still in progress.
 
Event Description
Description of event according to short form complaint filed: it is alleged that "[pt] received a gunther tulip filter on (b)(6) 2011. " patient outcome: it is alleged that [pt] was injured without further explanation. Hospital and medical records have been requested but not yet provided.
 
Manufacturer Narrative
(b)(4). Corrected pma/510(k) # from k090140 to k043509. Corrected from malfunction to serious injury. The event is currently under investigation. A supplemental report will be provided upon conclusion.
 
Event Description
This additional information was received on 024/18/2017 as follows: the plaintiff allegedly received device implant on (b)(6) 2011 for prevention of blood clot injury after myocardial infarction and massive bilateral pe. The plaintiff alleges device migration, device tilt, vena cava perforation, bleeding, migration of ivc filter and erosion through the cava, and 4 perforated tines after implant of device.
 
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Brand NameGUNTHER TULIP FEMORAL VENA CAVA FILTER SET
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
thomas hessner kirk
400 daniels way
bloomington, IN 47404
8004574500
MDR Report Key6529073
MDR Text Key248016548
Report Number3002808486-2017-01034
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
PMA/PMN Number
K043509
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Attorney
Type of Report Initial,Followup,Followup
Report Date 08/17/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberIGTCFS-65-FEM
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date04/15/2017
Device Age42 MO
Event Location No Information
Date Manufacturer Received04/18/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/22/2010
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: 04/28/2017 Patient Sequence Number: 1
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