BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK2 BALLOON CATHETER

    MDR report key: 1832058 · Received September 13, 2010

    Report

    Report Number
    2134265-2010-03970
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    August 17, 2010
    Report Date
    August 20, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE RETURNED DEVICE WAS ATTACHED TO AN ENCORE INFLATION DEVICE AND A PINHOLE LEAK WAS IDENTIFIED IN THE BALLOON MATERIAL. THE LEAK WAS NOTED APPROXIMATELY 3.5CM PROXIMAL TO THE PROXIMAL EDGE OF THE PROXIMAL MARKER BAND. MICROSCOPIC EXAMINATION OF THE BALLOON MATERIAL AND MARKER BAND COULD NOT IDENTIFY ANY ISSUES WHICH COULD POTENTIALLY HAVE CONTRIBUTED TO THE LEAK. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) TREATMENT PROCEDURE, A HOLE IN THE BALLOON MATERIAL WAS NOTED. THE DE NOVO LESION WAS LOCATED IN THE MILDLY CALCIFIED AND MILDLY TORTUOUS LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 15MM X 1.5MM MAVERICK 2 MONORAIL BALLOON CATHETER WAS ADVANCED TO THE LESION AND ATTEMPTS TO INFLATE THE BALLOON FAILED. A POSSIBLE HOLE IN THE BALLOON MATERIAL WAS REPORTED. THE BALLOON CATHETER WAS REMOVED FROM THE PATIENT WITHOUT INCIDENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) TREATMENT PROCEDURE, A HOLE IN THE BALLOON MATERIAL WAS NOTED. THE DE NOVO LESION WAS LOCATED IN THE MILDLY CALCIFIED AND MILDLY TORTUOUS LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 15MM X 1.5MM MAVERICK 2 MONORAIL BALLOON CATHETER WAS ADVANCED TO THE LESION AND ATTEMPTS TO INFLATE THE BALLOON FAILED. A POSSIBLE HOLE IN THE BALLOON MATERIAL WAS REPORTED. THE BALLOON CATHETER WAS REMOVED FROM THE PATIENT WITHOUT INCIDENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAVERICK2 BALLOON CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - GALWAY H7493892815150 0013223869

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR