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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 Problems Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/12/2020
Event Type  malfunction  
Manufacturer Narrative
Name and address: postal code: (b)(6). Occupation: senior clinical risk advisor. 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, during a filter retrieval a snare component detached. The attachment of the device to control the snare came loose and detached, which left the snare "free moving". The user was able to remove the component without issue. No portion of the device was left inside the patient. This did not result in any additional procedures or prolonged hospitalization. The patient did not experience any adverse effects due to this occurrence.
 
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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
jason crouch
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key11021663
MDR Text Key222304663
Report Number1820334-2020-02320
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K073374
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/06/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberGTRS-200-RB
Device Lot Number13351436
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/08/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/06/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/31/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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