BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTAGE BALLOON CATHETER INFLATION DEVICE

    MDR report key: 2061580 · Received April 18, 2011

    Report

    Report Number
    2134265-2011-01337
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    March 22, 2011
    Report Date
    March 22, 2011
    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

    (B)(4). 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 PREPARATION FOR A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, AN INCORRECT PRESSURE READING OCCURRED. DURING PREPARATION THE PRESSURE GAUGE OF THE ADVANTAGE INFLATION UNIT DID NOT MOVE. THE PROCEDURE WAS COMPLETED WITH ANOTHER ADVANTAGE INFLATION UNIT. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    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 14076448

    Patients

    Seq Age Sex Outcome Treatment
    1