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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 Problem Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/15/2016
Event Type  Malfunction  
Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable. Patient code: no known impact or consequence to patient. Device code: device operates differently than expected is not labeled. The event is currently under investigation.

 
Event Description

During a ivc filter removal, information was provided that the snare broke. This happened after the doctor looped the filter and was pulling gentle pressure on the snare so that he could re-sheath the filter. The snare snapped open and the filter released. The user opened another snare and was able to retrieve the filter successfully. A section of the device did not remain inside the patient's body. The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.

 
Manufacturer Narrative

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 investigation gave no indications that this device was not manufactured according to specifications. An investigation of the returned device found the loop wire had separated from the handle. The wires of the retrieval loop itself had fractured; these wires were squeezed and damaged in other areas. A scanning electron microscopy (sem) investigation of the loop did not reveal any sign of inclusion in the wires. Therefore, the exact reason for the loop and the loop wire to separate cannot be determined; but it is suggested that the device was exposed to manipulation beyond its intended use during attempts to re-sheath the filter. Instructions for use state that excessive force should not be used to retrieve the filter. Nothing indicates that the device did not perform as intended. Monitoring will be conducted for similar complaints. Per the risk assessment, no further action is required. The device has been archived.

 
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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 Key5793465
MDR Text Key49494357
Report Number1820334-2016-00626
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
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 04/21/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/14/2016
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/09/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/21/2016
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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