BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM (TM) MAVERICK (TM)

    MDR report key: 2230957 · Received September 1, 2011

    Report

    Report Number
    2134265-2011-03738
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 11, 2011
    Report Date
    August 12, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS WITH BLOOD AND CONTRAST IN THE INFLATION LUMEN. INSPECTION OF THE BALLOON IN A DEFLATED STATE REVEALED SCRATCHES ON THE BALLOON MATERIAL. THERE WAS NO DAMAGE TO THE DEVICE OR SHAFT PRIOR TO INFLATION AND SUBSEQUENT SHAFT BURST. AN INFLATION DEVICE WAS FILLED WITH WATER IN AN ATTEMPT TO LOCATE ANY BALLOON DAMAGE. WHILE INFLATING THE DEVICE, THE SHAFT BURST DUE TO HARDENED CONTRAST IN THE DISTAL END OF THE INFLATION LUMEN, WHICH OCCLUDED THE INFLATION LUMEN MAKING IT IMPOSSIBLE TO INFLATE THE BALLOON. UNABLE TO INFLATE THE BALLOON DUE TO THE SHAFT BURST, A SYRINGE WITH A NEEDLE TIP WAS USED. THE SYRINGE WAS FILLED WITH WATER AND INSERTED BETWEEN THE INNER LUMEN AND OUTER SHAFT BURST AREA. A PINHOLE WAS FOUND 4MM FROM THE PROXIMAL EDGE OF THE DISTAL RO MARKERBAND. THERE IS NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. THE SHAFT BURST WAS NOT REPORTED IN THE EVENT DESCRIPTION AND RESULTED FROM FUNCTIONAL TESTING IN THE DEVICE ANALYSIS LAB. THE BALLOON BURST WAS CONFIRMED. 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 CORONARY INTERVENTION PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 15MM X 2.75MM QUANTUM MAVERICK MONORAIL BALLOON WAS CHOSEN FOR THE PROCEDURE WHEN THE BALLOON RUPTURED AT THE NOMINAL PRESSURE DURING THE 1ST INFLATION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 15MM X 2.75MM QUANTUM MAVERICK MONORAIL BALLOON WAS CHOSEN FOR THE PROCEDURE WHEN THE BALLOON RUPTURED AT THE NOMINAL PRESSURE DURING THE 1ST INFLATION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT 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 QUANTUM (TM) MAVERICK (TM) CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493808015270 13415068

    Patients

    Seq Age Sex Outcome Treatment
    1