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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 N/A
Device Problems Crack (1135); Deformation Due to Compressive Stress (2889)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/18/2017
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Investigation: a review of the complaint history, device history record, manufacturing instructions, quality control, and visual inspection of the returned device was conducted during the investigation. The complete retrieval device is returned with the retrieved filter. Investigation revealed a 7 mm crack in the distal tip of the blue sheath and besides the tip being damaged, the sheath is compressed in more areas. There is no evidence to suggest the finished product was not made to specifications. Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode. There were no other reported complaints for this lot number. The findings suggest that the retrieval device was exposed to manipulation/strength beyond its intended design during attempts to collapse and retrieve the filter. However, based on the information provided and the results of our investigation, a definitive root cause could not be determined. Per the risk assessment, no further action is warranted. No harm to the patient was reported. Monitoring will continue to be performed for similar complaints.

 
Event Description

An international customer reported that, during an inferior vena cava filter retrieval, the blue sheath of a gunther tulip vena cava filter retrieval set buckled in three separate locations. The user was unable to advance a wire retrograde. Further information regarding the effect on the patient was requested, but not provided.

 
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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 Key6873863
MDR Text Key86604788
Report Number1820334-2017-02817
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial
Report Date 09/18/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/18/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue NumberGTRS-200-RB
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/05/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/30/2016
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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