BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENTINOL NITINOL BILLARY STENT SYSTEM

    MDR report key: 1830033 · Received September 10, 2010

    Report

    Report Number
    2134265-2010-04231
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    August 17, 2010
    Report Date
    August 17, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    FGE
    PMA / PMN Number
    K032025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID #2134265-2010-04230. IT WAS REPORTED THAT DURING PREPARATIONS FOR A PERCUTANEOUS INTERVENTION (PCI) PROCEDURE A LOOSE TIP OCCURRED. A SENTINOL BIL 7X78X1350 STENT HAD BEEN SELECTED TO TREAT AN UNSPECIFIED LESION. THE DEVICE WAS FLUSHED AND AN ATTEMPT WAS MADE TO LOAD THE DEVICE ON A WIRE; HOWEVER THE TIP APPEARED TO MOVE. THE DEVICE WAS EXCHANGED FOR ANOTHER SENTINOL BIL 7X78X1350 STENT AND THE TIP OF THIS 2ND DEVICE APPEARED TO MOVE AS WELL. THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENTINOL NITINOL BILLARY STENT SYSTEM CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - MAPLE GROVE H7493894878010 0013314262

    Patients

    Seq Age Sex Outcome Treatment
    1