BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE(TM) BALLOON DILATATION CATHETER

    MDR report key: 1904989 · Received November 22, 2010

    Report

    Report Number
    3005099803-2010-04769
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 25, 2010
    Report Date
    October 29, 2010
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KOG
    PMA / PMN Number
    K974788
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE BALLOON WAS TORN LONGITUDINALLY. THE CATHETER WAS INSPECTED FOR COSMETIC DEFECTS AS NONE WERE FOUND. THE REPORTED DEFECT WAS CONFIRMED. THIS FAILURE OCCURS WHEN PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE LIMIT THE PERFORMANCE OF THE BALLOON (E.G. SHARP EXTERIOR SOURCES). THE ROOT CAUSE OF THIS COMPLAINT WILL BE CLASSIFIED AS OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED BALLOON DILATATOR WAS USED DURING AN ESOPHAGEAL DILATATION PROCEDURE PERFORMED ON (B)(6) 2010 ON AN ADULT PATIENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE BALLOON WAS INFLATED AT 5 ATM, IT RUPTURED. NO PIECES OF THE BALLOON WERE DETACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "GOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRE(TM) BALLOON DILATATION CATHETER ENDOSCOPE AND/OR ACCESSORIES, DILATOR, ESOPHAGEAL KOG BOSTON SCIENTIFIC - CORK M00558440 0013371575

    Patients

    Seq Age Sex Outcome Treatment
    1