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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, manufacturing instructions, quality control, and visual inspection of the returned device was conducted during the investigation. The coaxial sheath system was returned. The hub had separated from the introducer sheath. Investigation revealed a sheath flaring which was conforming to specifications. A similar test fitting was attached to the complaint sheath and even by strong 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. 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. Based on the information provided, examination of the returned product, and the results of our investigation, a definite root cause could not be determined. It is likely, however, that operational context contributed to the event. Per the [quality engineering] 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
As reported to customer relations, "the sheath separated from the hub. A new gunther tulip vena cava filter retrieval set was opened and used to complete the procedure. " the patient did not have any unintended section of the device left inside their body. The initial reporter stated there was no adverse event related to this separation of the hub from the sheath.
 
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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 Key7132741
MDR Text Key267958458
Report Number1820334-2017-04308
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Radiologic Technologist
Type of Report Initial,Followup
Report Date 04/06/2018
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? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/15/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/31/2017
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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