BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM? MAVERICK?

    MDR report key: 3131935 · Received May 29, 2013

    Report

    Report Number
    2134265-2013-03689
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 2, 2013
    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

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: THE QUANTUM MAVERICK CATHETER WAS RECEIVED INSIDE A CARRIER TUBE (HOOP). MAGNIFIED INSPECTION REVEALED NO DAMAGE. THE DEVICE WAS INFLATED TO RATED BURST PRESSURE (RBP) WITH AN INFLATION DEVICE FILLED WITH WATER. THE DEVICE MAINTAINED RBP FOR FIVE (5) MINUTES WITH NO INDICATION OF ANY LEAKS OR OTHER IRREGULARITIES. THE DEVICE WAS DEFLATED BY APPLYING NEGATIVE PRESSURE WITH THE INFLATION DEVICE. FUNCTIONAL TESTING REVEALED NO EVIDENCE OF THE ALLEGED BALLOON BURST. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS NOT CONFIRMED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN AN UNSPECIFIED CALCIFIED VESSEL. A 2.0MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS USED FOR PREDILATATION OF THE TARGET LESION. DURING THE FIRST INFLATION, THE BALLOON RUPTURED BEFORE IT REACHED THE RATED BURST PRESSURE. THE BALLOON WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE NOTED AND THE PATIENT'S CONDITION WAS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN AN UNSPECIFIED CALCIFIED VESSEL. A 2.0MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS USED FOR PREDILATATION OF THE TARGET LESION. DURING THE FIRST INFLATION, THE BALLOON RUPTURED BEFORE IT REACHED THE RATED BURST PRESSURE. THE BALLOON WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE NOTED AND THE PATIENT'S CONDITION WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234408 QUANTUM? MAVERICK? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493808012200 15475108

    Patients

    Seq Age Sex Outcome Treatment
    1