BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTAGE BALLOON CATHETER INFLATION DEVICE

    MDR report key: 2803108 · Received October 24, 2012

    Report

    Report Number
    2134265-2012-06577
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    August 23, 2012
    Report Date
    September 26, 2012
    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

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MANUFACTURER: DIRECT PRODUCT ANALYSIS WAS NOT POSSIBLE AS THE DEVICE IS NOT BEING RETURNED FROM THE USER FACILITY AS IT WAS DISPOSED OF. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED PRIOR TO PATIENT CONTACT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION TREATMENT PROCEDURE GAUGE ISSUES OCCURRED. THE LESION WAS 99% STENOSED. THE PHYSICIAN WAS ABLE TO INCREASE THE PRESSURE ON THE ADVANTAGE 26 INFLATION DEVICE TO FIVE OR SEVEN ATMOSPHERES, AT WHICH POINT THE PRESSURE WOULD DECREASE. THE BALLOON WAS NEVER INFLATED. THE PHYSICIAN CHANGED TO ANOTHER OF THE SAME INFLATION DEVICE AND USING THE SAME BALLOON WAS ABLE TO COMPLETE THE PROCEDURE. NO PATIENT 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 0015277431

    Patients

    Seq Age Sex Outcome Treatment
    1 BALLOON CATHETER: SCOREFLEX