BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM? MAVERICK?

    MDR report key: 3111937 · Received May 14, 2013

    Report

    Report Number
    2134265-2013-03249
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 16, 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

    DEVICE EVALUATED BY MFR.: THE QUANTUM MAVERICK CATHETER WAS RECEIVED WITH NO ORIGINAL PACKAGING OR OTHER DEVICES. MAGNIFIED INSPECTION REVEALED NO DAMAGE TO THE CATHETER. 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. AFTER CONFIRMING THE DEVICE MAINTAINED RBP, 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, A BALLOON PINHOLE WAS NOTED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE CALCIFIED AND SEVERELY TORTUOUS UNSPECIFIED ARTERY. A 15MM X 2.5MM QUANTUM MAVERICK BALLOON CATHETER WAS USED TO DILATE THE LESION. UPON INFLATION AT AN UNSPECIFIED PRESSURE A PINHOLE IN THE BALLOON WAS NOTED. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION WAS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, A BALLOON PINHOLE WAS NOTED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE CALCIFIED AND SEVERELY TORTUOUS UNSPECIFIED ARTERY. A 15MM X 2.5MM QUANTUM MAVERICK BALLOON CATHETER WAS USED TO DILATE THE LESION. UPON INFLATION AT AN UNSPECIFIED PRESSURE A PINHOLE IN THE BALLOON WAS NOTED. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211767 QUANTUM? MAVERICK? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493808015250 15878032

    Patients

    Seq Age Sex Outcome Treatment
    1