BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE BALLOON DILATATION CATHETER

    MDR report key: 1193250 · Received October 7, 2008

    Report

    Report Number
    3005099803-2008-05092
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    September 8, 2008
    Report Date
    September 9, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORK LTD.
    Product Code
    KNQ
    PMA / PMN Number
    K971320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SAME CASE AS #3005099803-2008-05093 . IT WAS REPORTED THAT DURING PREPARATION FOR AN UNSPECIFIED PROCEDURE, DAMAGE TO THE DEVICE WAS NOTED. IT WAS FOUND, PRIOR TO USE, THAT THE CRE 18-20 MM 8 CM F/G BALLOON DILATATION CATHETER WAS BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE DILATATION BALLOON. AS THERE WAS NO PATIENT CONTACT, NO PATIENT COMPLICATIONS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRE BALLOON DILATATION CATHETER KNQ BOSTON SCIENTIFIC CORK LTD. M00558380 0011837971

    Patients

    Seq Age Sex Outcome Treatment
    1