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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
Model Number G13287
Device Problem Material Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/30/2019
Event Type  Malfunction  
Manufacturer Narrative

This report includes information known at this time. A follow-up report will be submitted should additional relevant information become available.

 
Event Description

It was reported, during a filter (manufacturer not specified) removal procedure, a gunther tulip vena cava filter retrieval set was utilized. After the filter was snared, the physician used force to advance the sheath from the set over the filter resulting in the outer portion of the sheath separating from the hub. The sheath was removed in an unspecified manner and another gunther tulip vena cava filter retrieval set sheath was placed. It was reported no portion of the complaint sheath was left in the patient. Additionally, the patient did not require any additional procedures or experience any adverse effects as a result of this occurrence. Additional information regarding event details has been requested but has not yet been received.

 
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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
larry pool
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key8340839
MDR Text Key136296087
Report Number1820334-2019-00332
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 COMPANY REPRESENTATIVE,USER F
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/30/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/14/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberG13287
Device Catalogue NumberGTRS-200-RB
Device LOT Number9411327
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/04/2019
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/24/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/18/2018
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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