BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE BALLOON DILATATION CATHETER

    MDR report key: 933946 · Received October 26, 2007

    Report

    Report Number
    6000122-2007-00026
    Event Type
    Malfunction
    Date Received
    October 26, 2007
    Date of Event
    October 1, 2007
    Report Date
    October 2, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORK LTD
    Product Code
    KCG
    PMA / PMN Number
    K974788
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE HAS BEEN RECEIVED BUT AN EVALUATION HAS NOT BEEN PERFORMED. THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND IT IS NOT POSSIBLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE OF THE EVENT. AN EVALUATION OF THE RETURNED DEVICE, A REVIEW OF THE DEVICE HISTORY RECORD AND A REVIEW OF THE PRODUCT FAMILY COMPLAINT TREND REPORT ARE IN PROGRESS; RESULTS WILL BE PROVIDED IN A FOLLOW-UP MEDWATCH REPORT.

    Description of Event or Problem · 1

    ON OCTOBER 2, 2007, IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRACHEAL DILATATION PROCEDURE USING A CRE DILATATION BALLOON CATHETER WAS PERFORMED (MALE PATIENT). ACCORDING TO THE COMPLAINT. "THE BALLOON WAS SET UP USING READI-CAT 2 CONTRAST MEDIUM, ADVANCED THROUGH THE LMA [DEVICE] (LARYNGEAL MASK AIRWAY)...INFLATED UP TO 20MM." THEN, WHEN ATTEMPTING TO DEFLATE THE BALLOON AFTER THE PROCEDURE WAS COMPLETED, THE "BALLOON WAS UNABLE TO DEFLATE COMPLETELY." REPORTEDLY, THE "BALLOON WOULD NOT COME BACK THROUGH THE LMA AND THE LMA AND [THE] BALLOON HAD TO BE REMOVED FROM THE PATIENT WITH THE BALLOON IN THE LMA PARTIALLY INFLATED." INFORMATION PROVIDED TO BOSTON SCIENTIFIC, REVEALED THAT AT THE CONCLUSION OF THE PROCEDURE, THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRE BALLOON DILATATION CATHETER KCG BOSTON SCIENTIFIC CORK LTD M00558440 9783920

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR LARYNGEAL MASK AIRWAY