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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
Catalog Number GTRS-200-RB
Device Problem Split (2537)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). The event is currently under investigation.

 
Event Description

The split of the sheath was originally report on 1820334-2017-00968 in the description of the event. During the course of the investigation, it was determined that the customer had been shipped a (b)(4). This mdr is being submitted to capture the actual sheath used during the event. No harm to the patient was reported based on the sheath split.

 
Manufacturer Narrative

Investigation - evaluation: a review of the complaint history and specifications was completed during this evaluation. The lot number of the device is not known; accordingly a review of the device history record could not be conducted. The complaint device was not returned; therefore no physical examination could be performed and no imaging was provided. It is assumed the sheath was damaged at the distal tip. However, it should be noted that "a 4-french sheath and a long 10-french cook sheath were used in the attempt", but the cook medical ivc filter retrieval device does not contain a 4fr nor a 10fr sheath. There is no evidence to suggest that this retrieval device was not manufactured according to specifications and nothing indicates that it did not perform as intended. Based on the information provided, no product returned, and the results of our investigation; a definitive root cause could not be determined. Cook will reopen its investigation if further information is received.

 
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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 Key6833857
MDR Text Key84260776
Report Number1820334-2017-00996
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 CONSUMER
Reporter Occupation ATTORNEY
Type of Report Initial,Followup
Report Date 10/04/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/31/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
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 Received09/19/2017
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

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