BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE BALLOON CATHETER

    MDR report key: 1181523 · Received September 25, 2008

    Report

    Report Number
    3005099803-2008-04822
    Event Type
    Malfunction
    Date Received
    September 25, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 1, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    KNQ
    PMA / PMN Number
    K971320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ESOPHAGEAL DILATION PROCEDURE THE BALLOON FAILED TO HOLD PRESSURE. DURING UNPACKING, A CRE 15-18MM 8CM F/G BALLOON CATHETER FELT "SOFTER" THAN PREVIOUSLY USED SAME DEVICES AT THE FACILITY. THE CRE 15-18MM 8CM F/G BALLOON CATHETER WAS ADVANCED TO THE TARGET ESOPHAGEAL STRICTURE. THE BALLOON WAS INFLATED TO 7 ATMOSPHERES WHEN THE PRESSURE "RAPIDLY DECREASED." SUBSEQUENT ATTEMPTS TO INFLATE THE DEVICE WERE UNSUCCESSFUL. THE DEVICE WAS EXCHANGED FOR ANOTHER OF THE SAME DEVICE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED WITH THE PATIENT'S CURRENT CONDITION LISTED AS "STABLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRE BALLOON CATHETER KNQ BOSTON SCIENTIFIC M00558370 11711837

    Patients

    Seq Age Sex Outcome Treatment
    1