BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACHALASIA BALLOON DILATATION CATHETER

    MDR report key: 1182291 · Received September 30, 2008

    Report

    Report Number
    3005099803-2008-04951
    Event Type
    Malfunction
    Date Received
    September 30, 2008
    Date of Event
    September 19, 2007
    Report Date
    September 26, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORK, LTD.
    Product Code
    KNQ
    PMA / PMN Number
    K050232
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE DEVICE REVEALED THAT THE CATHETER SHAFT WAS FOUND TO BE BROKEN, 23.5 CM FROM THE DISTAL TIP. THE CAUSE OF THE FRACTURE IS UNDETERMINED, HOWEVER, IT SHOULD BE NOTED THAT THE DEVICE WAS USED BEYOND ITS EXPIRATION DATE. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE PERTINENT LOT WAS REVIEWED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO ADDITIONAL COMPLAINTS HAVE BEEN REPORTED FOR THE LOT.

    Description of Event or Problem · 1

    IN 2007, IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ACHALASIA BALLOON DILATATION CATHETER WAS USED DURING A ENDOSCOPIC ESOPHAGEAL DILATATION PROCEDURE (PATIENT AGE, GENDER AND WEIGHT UNKNOWN) A WEEK PRIOR. ACCORDING TO THE COMPLAINANT, "THE CATHETER BROKE AT THE END OF THE PROCEDURE, JUST ABOVE THE BALLOON." THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACHALASIA BALLOON DILATATION CATHETER KNQ BOSTON SCIENTIFIC CORK, LTD. M00553110 4158613

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK