BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENCORE BALLOON CATHETER INFLATION DEVICE

    MDR report key: 2862917 · Received December 10, 2012

    Report

    Report Number
    2134265-2012-07240
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 9, 2012
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MAV
    PMA / PMN Number
    K955869
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THE DEVICE WAS BLOCKED WITH GREEN CONTRAST MEDIA. THE DEVICE WAS DISMANTLED AND PLACED IN WARM WATER TO DISSOLVE THE CONTRAST MEDIA BEFORE FUNCTIONALLY TESTING. THE UNIT PASSED THE FUNCTIONAL LEAK TEST, GAUGE TEST, LOCKING MECHANISM TEST, VACUUM TEST, AND PRESSURE TEST. NO ISSUES WERE NOTED DURING THE INFLATION AND DEFLATION TEST. 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE A GAUGE ISSUE OCCURRED. A ENCORE 26 SINGLE BALLOON CATHETER INFLATION DEVICE WAS USED TO INFLATE A NON BSC BALLOON CATHETER. HOWEVER, DURING THE INFLATION THE PRESSURE GAUGE DID NOT GO UP. UNDER FLUOROSCOPY THE BALLOON WAS OBSERVED TO BE FULLY INFLATED. UPON CONTINUING TO INCREASE PRESSURE, THE DEVICE "STAYED FLAT" AND THE GAUGE OF THE DEVICE SUDDENLY "JUMPS" TO 10 ATMS. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS LISTED AS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE A GAUGE ISSUE OCCURRED. A ENCORE 26 SINGLE BALLOON CATHETER INFLATION DEVICE WAS USED TO INFLATE A NON BSC BALLOON CATHETER. HOWEVER, DURING THE INFLATION THE PRESSURE GAUGE DID NOT GO UP. UNDER FLUOROSCOPY THE BALLOON WAS OBSERVED TO BE FULLY INFLATED. UPON CONTINUING TO INCREASE PRESSURE, THE DEVICE "STAYED FLAT" AND THE GAUGE OF THE DEVICE SUDDENLY "JUMPS" TO 10 ATMS. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS LISTED AS STABLE.

    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 15107252

    Patients

    Seq Age Sex Outcome Treatment
    1