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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 Problems Material Separation (1562); Split (2537)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/22/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). 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 that while attempting to remove an inferior vena cava (ivc) filter, the gunther tulip vena cava filter retrieval set sheath (blue outer portion) detached from the hub (white). The dilator was re-introduced and the sheath and dilator were pulled out of the patient's anatomy as a unit. The ivc filter was able to be successfully retrieved. According to the initial reporter, 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 Contact
larry pool
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key7314245
MDR Text Key101718601
Report Number1820334-2018-00635
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,HEALTH
Reporter Occupation RADIOLOGIC TECHNOLOGIST
Type of Report Initial,Followup,Followup
Report Date 06/06/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/05/2018
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
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/22/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/30/2017
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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