BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENCORE BALLOON CATHETER INFLATION DEVICE

    MDR report key: 2000412 · Received February 24, 2011

    Report

    Report Number
    2134265-2011-00701
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    January 27, 2011
    Report Date
    January 27, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MAV
    PMA / PMN Number
    K955869
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE ENCORE 26 SINGLE UNIT WAS RETURNED WITH THE DEVICE HOUSING SEPARATED AND THE GAUGE UNATTACHED. THE DEVICE WAS DISASSEMBLED AND IT WAS OBSERVED THAT ONE TAB WAS BENT OUT OF SHAPE AND MISALIGNED WITH THE CONNECTOR INTO WHICH IT SNAPS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS MANUFACTURING RELATED. (B)(4)

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT : (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) PROCEDURE GAUGE DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE OBTUSE MARGINAL (OM) ARTERY. A PROMUS STENT WAS SUCCESSFULLY DEPLOYED TO TREAT THE TARGET LESION. WHILE ATTEMPTING TO DEPLOY A SECOND PROMUS STENT, THE GAUGE OF THE ENCORE INFLATION DEVICE "FELL OFF" AND THE DEVICE "BROKE APART". THE STENT BALLOON WAS DEFLATED WITH A SYRINGE. ANOTHER OF THE SAME INFLATION DEVICE WAS USED TO SUCCESSFULLY DEPLOY THE STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS US FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) PROCEDURE GAUGE DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE OBTUSE MARGINAL (OM) ARTERY. A PROMUS STENT WAS SUCCESSFULLY DEPLOYED TO TREAT THE TARGET LESION. WHILE ATTEMPTING TO DEPLOY A SECOND PROMUS STENT, THE GAUGE OF THE ENCORE INFLATION DEVICE "FELL OFF" AND THE DEVICE "BROKE APART". THE STENT BALLOON WAS DEFLATED WITH A SYRINGE. ANOTHER OF THE SAME INFLATION DEVICE WAS USED TO SUCCESSFULLY DEPLOY THE STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS US FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENCORE BALLOON CATHETER INFLATION DEVICE SYRINGE, BALLOON INFLATION MAV BOSTON SCIENTIFIC - CORK H74904526011

    Patients

    Seq Age Sex Outcome Treatment
    1 (2) PROMUS STENTS