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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK, INC. GUNTHER TULIP FILTER, INTRAVASCULAR, CARDIOVASCULAR

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COOK, INC. GUNTHER TULIP FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number G52918
Device Problems Bent (1059); Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/30/2018
Event Type  Malfunction  
Event Description

Upon positioning the device within the patient, it was noticed the filter was damaged/misshapen. The support legs of the filter were bent in an upward position. When this was noticed, the filter was unable to be removed. The filter was then deployed in the inferior vena cava. After this the doctor then retrieved this filter from a jugular approach. After the retrieval was successfully performed, another filter was placed into the inferior vena cava without difficulty. Manufacturer response for gunther tulip vena cava filter, gunther tulip vena cava filter (per site reporter): vendor will retrieve the device from the facility and perform an evaluation.

 
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Brand NameGUNTHER TULIP
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
COOK, INC.
750 daniels way
bloomington IN 47404
MDR Report Key7618960
MDR Text Key111733698
Report Number7618960
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 06/15/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/20/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device EXPIRATION Date02/21/2021
Device MODEL NumberG52918
Device Catalogue NumberIGTCFS-65-1-UNI-TULIP
Device LOT NumberE3692849
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/15/2018
Device Age1 dy
Event Location Hospital
Date Report TO Manufacturer06/15/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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