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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 Problems Kinked (1339); Material Separation (1562)
Patient Problem No Code Available (3191)
Event Date 03/19/2013
Event Type  Injury  
Manufacturer Narrative

Common name & product code = unavailable as the device lot number, rpn, and gpn are unknown. Pma/510(k) number = unavailable as the device lot number, rpn, and gpn are unknown. (b)(4). Other-medical records obtained during investigation for medwatch 3002808486-2016-00384. This report includes information known at this time.  a follow-up report will be submitted should additional relevant information become available.

Event Description

Information for this report was obtained utilizing medical records during investigation for medwatch 3002808486-2016-00384. It was reported that during an inferior vena cava (ivc) filter retrieval procedure, a cook medical simmons 1 catheter was inserted into the patient's right jugular vein and formed below the ivc filter. The catheter was then wrapped around the filter in attempt to dislodge it from the caval wall, and became kinked and tightly attached to the filter, rendering it unable to be removed. The catheter then fragmented and broke off inside of the patient's inferior vena cava, while attached to the filter. Removal of the catheter was attempted, at which point multiple filter legs were inverted and dislodged, causing malposition of the filter. As the catheter fragments were unable to be engaged using a jugular approach, the right common femoral vein was accessed with a micropuncture needle under ultrasound guidance and a sheath (6 fr) was placed. The catheter fragments were able to be successfully retrieved.

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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 Key7190534
MDR Text Key97346137
Report Number1820334-2018-00133
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 ATTORNEY
Type of Report Initial,Followup
Report Date 02/22/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/15/2018
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? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/19/2018
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: 01/15/2018 Patient Sequence Number: 1