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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 Material Separation (1562)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
A review of the complaint history, specifications, and photographic inspection of the device was conducted during the investigation. The device is shipped with instructions for use (ifu), which advise to avoid use of excessive force. A photograph of the complaint device was provided. According to the photo, the hub had separated from the blue sheath. The sheath flaring appears intact. The flare appears to be properly shaped and sized in the photo; however, without return of the complaint device, the actual flare dimension and through hole of the connector cap cannot be measured. Also, the black catheter of the retrieval loop system is placed inside the blue sheath and the separated hub is placed next to it. Therefore, it is probable that excessive force during the filter retrieval procedure caused the hub to separate from the sheath, and that the catheter was removed and replaced inside the blue sheath after the separation. However, based on the information provided, no product returned, and the results of our investigation; a definitive root cause could not be determined. Per the risk assessment, no further action is warranted. Monitoring will continue to be performed for similar complaints.
 
Manufacturer Narrative
(b)(4). The event is currently under investigation.
 
Event Description
It was reported a piece separated from the outer sheath. Reportedly the device did make patient contact however it was outside of the body and thus nothing was left behind and no additional procedures were needed. No additional information was available at the time of this report.
 
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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 Key6149084
MDR Text Key130358698
Report Number1820334-2016-01424
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
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/22/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberGTRS-200-RB
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/29/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/06/2016 Patient Sequence Number: 1
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