BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENCORE BALLOON CATHETER INFLATION DEVICE

    MDR report key: 2872374 · Received December 13, 2012

    Report

    Report Number
    2134265-2012-08103
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    December 4, 2012
    Report Date
    December 4, 2012
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MAV
    PMA / PMN Number
    K955869
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE UNIT COMPONENTS WERE VISUALLY EXAMINED FOR ANY DAMAGE, DEFECT AND FOREIGN MATTER AND NO ISSUES WERE NOTED. A FUNCTIONAL TEST OF THE COMPLAINT DEVICE WAS CARRIED OUT. LEAK TEST TO DETERMINE THE PRESENCE OF LEAKS. NO AIR BUBBLES WERE EMITTED FROM THE DEVICE HENCE THE UNIT PASSED. GAUGE ACCURACY TEST TO ASSESS THE ACCURACY OF THE GAUGE UNDER PRESSURIZATION AND AT 0 PRESSURE. THE RESULTS WERE WITHIN THESE PARAMETERS. SIDE LOAD INVOLVED APPLYING PRESSURE TO THE PROXIMAL END OF THE HANDLE. THE UNIT HAS PASSED IF THE UNIT MAINTAINS A VACUUM IN THIS POSITION. THE UNIT PASSED. PRESSURE DAMPING TEST TO ENSURE THE UNIT FALLS. THE UNIT PASSED. THE UNIT WAS PRIMED WITH 5ML OF WATER BEFORE WITHDRAWING THE PLUNGER TO CREATE A VACUUM. THERE WAS NO BUBBLE LEAKAGE. THE DEVICE PASSED THE DEVICE LOCKING MECHANISM TEST. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE WAS UNABLE TO BE CONFIRMED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    AE OR PRODUCT PROBLEM: CORRECTED FROM REPORTED ISSUE IS BOTH AN ADVERSE EVENT AND PRODUCT PROBLEM TO PRODUCT PROBLEM (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A PERCUTANEOUS CORONARY INTERVENTION TREATMENT PROCEDURE PLASTIC MATERIAL WAS FOUND INSIDE PACKAGING. IT WAS NOTED THAT THERE WAS A PIECE OF PLASTIC FOUND WITH THE ENCORE 26 INFLATION DEVICE. IT WAS BELIEVED THAT IT WAS PART OF THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A PERCUTANEOUS CORONARY INTERVENTION TREATMENT PROCEDURE, PLASTIC MATERIAL WAS FOUND INSIDE PACKAGING. IT WAS NOTED THAT THERE WAS A PIECE OF PLASTIC FOUND WITH THE ENCORE 26 INFLATION DEVICE. IT WAS BELIEVED THAT IT WAS PART OF THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A PERCUTANEOUS CORONARY INTERVENTION TREATMENT PROCEDURE PLASTIC MATERIAL WAS FOUND INSIDE PACKAGING. IT WAS NOTED THAT THERE WAS A PIECE OF PLASTIC FOUND WITH THE ENCORE 26 INFLATION DEVICE. IT WAS BELIEVED THAT IT WAS PART OF THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    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 15500556

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention