BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNTEL EMBOLECTOMY CATHETER, 4F, 80CM

    MDR report key: 1246432 · Received November 25, 2008

    Report

    Report Number
    2027111-2008-00064
    Event Type
    Other
    Date Received
    November 25, 2008
    Date of Event
    November 5, 2008
    Report Date
    November 25, 2008
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    DXE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE CATHETER WAS NOT RETURNED FOR EVAL AND THERE IS NO PRODUCT FROM LOTS 1063899 OR 1061343 REMAINING IN INVENTORY. WE HAVE REVIEWED THE DEVICE HISTORY RECORDS AND FOUND NO DEVIATIONS OR DISCREPANCIES IN OUR STANDARD MFG AND TESTING PROCEDURES. THE CER STATES THAT THE SYNTEL EMBOLECTOMY CATHETER WAS BEING USED FOR A GRAFT PROCEDURE. APPLIED PRODUCT INFO DATA SHEET SPECIFIES THAT THE EMBOLECTOMY CATHETER CONTRAINDICATED FOR VESSEL DILATION, ENDARTERECTOMY PROCEDURES, GRAFT CLEANING OR USE IN THE VENOUS SYSTEM. THESE PROCEDURES REQUIRE DIFFERENT, MORE ROBUST, CATHETER DESIGNS WHICH APPLIED ALSO MANUFACTURERS. GIVEN THE LACK OF INFO REGARDING THIS SPECIFIC INCIDENT, AND IN THE ABSENCE OF THIS SUBJECT DEVICE, IT IS NOT POSSIBLE TO DETERMINE THE CAUSE AND FAILURE MODE. AS A RESULT WE ARE CONCLUDING OUR INVESTIGATION AND CLOSING THIS INCIDENT FILE.

    Description of Event or Problem · 1

    "THE DISTAL END OF THE EMBOLECTOMY CATHETER CAME OFF IN THE PT DURING SURGERY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNTEL EMBOLECTOMY CATHETER, 4F, 80CM EMBOLECTOMY CATHETER DXE APPLIED MEDICAL RESOURCES A4F05

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization