BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTAGE BALLOON CATHETER INFLATION DEVICE

    MDR report key: 1882401 · Received October 26, 2010

    Report

    Report Number
    2134265-2010-04819
    Event Type
    Malfunction
    Date Received
    October 26, 2010
    Date of Event
    October 3, 2010
    Report Date
    October 4, 2010
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MAV
    PMA / PMN Number
    K955869
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE THE PRESSURE GAUGE DID NOT GO UP. THE 90% STENOSED LESION WAS LOCATED IN A SEVERELY TORTUOUS AND NON-CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. THE ADVANTAGE 26 INFLATION DEVICE WAS CONNECTED TO A NON BSC DEVICE AND IT WAS NOTED THAT THE GAUGE DID NOT GO UP MORE THEN EIGHT ATMOSPHERES WHEN INFLATION WAS PERFORMED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANTAGE BALLOON CATHETER INFLATION DEVICE SYRINGE, BALLOON INFLATION MAV BOSTON SCIENTIFIC - CORK H74904527011 13576233

    Patients

    Seq Age Sex Outcome Treatment
    1