BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6F-80CM (OREM) SYNTEL CATH

    MDR report key: 1823557 · Received August 27, 2010

    Report

    Report Number
    2027111-2010-00091
    Event Type
    Malfunction
    Date Received
    August 27, 2010
    Date of Event
    July 30, 2010
    Report Date
    August 27, 2010
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    DXE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT IS TO BE RETURNED FOR EVALUATION. A F/U REPORT WILL BE SENT ONCE MORE INFORMATION HAS BEEN OBTAINED.

    Description of Event or Problem · 1

    INCIDENT AS REPORTED: THROMBECTOMY PROCEDURE - "IT WAS REPORTED TO BARD (B)(4) THAT ON (B)(6) 2010, DURING A THROMBECTOMY PROCEDURE, THE PHYSICIAN USED A FIRST CATHETER (ITEM CODE CEO680ST) BUT THE BALLOON RUPTURED. THEREFORE, THE PHYSICIAN RETRIEVE THE DEVICE WITHOUT PROBLEM AND USED A SECOND CATHETER (ITEM CEO580ST) BUT THE SAME ISSUE OCCURRED (BALLOON RUPTURE). THEREFORE THE THROMBECTOMY PROCEDURE WAS NO PERFORMED DUE TO THIS EVENT. THE PHYSICIAN DECIDED TO PLACE A STENT." EVENT DATE (B)(6) 2010. PT OUTCOMES: NO PT COMPLICATION. THE PT IS REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F-80CM (OREM) SYNTEL CATH NONE DXE APPLIED MEDICAL RESOURCES CEO680ST 1083244

    Patients

    Seq Age Sex Outcome Treatment
    1