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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC UNKNOWN

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COOK INC UNKNOWN Back to Search Results
Catalog Number UNKNOWN
Device Problem Material Fragmentation (1261)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Type  Injury  
Manufacturer Narrative

(b)(4). The event is currently under investigation. A supplemental report will be provided upon conclusion.

Event Description

It was reported that two of the gunther tulip vena cava filter fine wires were broken, and a fragment of approximately one (1) centimeter (cm) of fine wire had embolized to the right upper lobe (rul) of the patient's lung. The filter was able to be removed; however, some extravascular wire was left inside of the patient's anatomy. The patient was noted to be returning for retrieval of the rul wire fragment. The user facility medwatch and additional information pertaining to event details has been requested, but is not available at this time.

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Manufacturer (Section D)
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
MDR Report Key7135345
MDR Text Key95448721
Report Number1820334-2017-04358
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
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/28/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/20/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Catalogue NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/15/2018
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

Date Received: 12/20/2017 Patient Sequence Number: 1