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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 Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, device history record, documentation, instructions for use (ifu), manufacturing instructions, specifications, quality control, and visual inspection of the returned device was conducted during the investigation. One unused, opened gunther tulip vena cava filter retrieval set was returned for evaluation. The hub was separated from the introducer sheath. The sheath flaring was measured to be within specification limits. A similar test fitting was attached to the complaint sheath and even by strongly pulling the fitting, did not slip the sheath. A document-based investigation was performed. There is no evidence to suggest the finished product was not made to specifications. Numerous design verification and validation activities have been performed to ensure that this device meets design requirements. Review of the device history record of the finished product shows no nonconforming events that could contribute to this failure mode. A complaint history search revealed that there were no other reported complaints for this lot number. Per the ifu, "excessive force should not be used to retrieve the filter. " based on the information provided, examination of the returned product, and the results of our investigation, the root cause for this event was determined to be related to product use/ handling as the device was likely exposed to strong pulling/manipulation. Per the risk assessment, no further action is required. Monitoring will continue to be performed for similar complaints.
 
Manufacturer Narrative
(b)(4). The event is currently under investigation. A follow up report will be submitted upon receipt of additional information or completion of the investigation.
 
Event Description
It was reported the facility and the district manager opened up the device to test it on the back table and it separated at the hub. There was no patient contact as the district manager was doing a sort of a demonstration.
 
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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 Key7132747
MDR Text Key253564669
Report Number1820334-2017-04309
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K073374
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 03/13/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/19/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG13287
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 Received02/20/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/30/2017
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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