BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM (TM) MAVERICK (TM)

    MDR report key: 2225956 · Received August 29, 2011

    Report

    Report Number
    2134265-2011-03619
    Event Type
    Malfunction
    Date Received
    August 29, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 3, 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

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

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: RECEIVED PRODUCT CONSISTED OF A QUANTUM MAVERICK BALLOON CATHETER WHICH HAD CONTRAST PRESENT IN THE GUIDEWIRE LUMEN AND BALLOON. THE BALLOON APPEARED TO BE PARTIALLY INFLATED. THE INNER SHAFT WAS BUCKLED DISTAL TO THE PROXIMAL MARKERBAND AND THE INNER AND OUTER SHAFT WERE BUCKLED PROXIMAL TO AND ON THE PROXIMAL BALLOON BOND. DAMAGE ON THE PROXIMAL WELD REGION IS THE PROBABLE CAUSE OF THE OUTER DIAMETER TO BE OUT OF SPECIFICATION. THE CATHETER WAS SOAKED IN A BATH OF CIRCULATING 37 DEGREE CELSIUS WATER FOR 24 HOURS TO ATTEMPT TO LOOSEN SOLIDIFIED CONTRAST IN THE GUIDEWIRE LUMEN AND BALLOON. USING AN INFLATION DEVICE FILLED WITH WARM WATER, THE DEVICE WAS CAREFULLY PRESSURIZED AND PURGED TO REMOVE RESIDUAL CONTRAST IN THE CATHETER. A SOLUTION CONTAINING A (B)(4) MIXTURE WAS USED TO PREP THE CATHETER ACCORDING TO THE DIRECTIONS FOR USE. THE CATHETER WAS PRESSURIZED TO RATED BURST PRESSURE (RBP) AND STABILIZED FOR FIVE MINUTES. THE CATHETER WAS THEN SUBJECT TO NEGATIVE PRESSURE AND THE BALLOON WAS DEFLATED. THE DEFLATION TIME EXCEEDED SPECIFICATION. THE DAMAGE TO THE DEVICE MOST LIKELY CONTRIBUTED TO THE DEFLATION ISSUE. 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE DEFLATION DIFFICULTY OCCURRED. THE 90% STENOSED LESION WAS LOCATED IN A MODERATELY TORTUOUS UNKNOWN ARTERY. AFTER STENTING WAS PERFORMED, THE QUANTUM MAV MON 12MM X 2.5MM BALLOON WAS USED FOR POST DILATING. AFTER THE SECOND INFLATION THE BALLOON WOULD NOT DEFLATE. A MINUTE LATER THE BALLOON SLIGHTLY DEFLATED AND WAS ABLE TO BE REMOVED OUTSIDE THE PATIENT¿S BODY. 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 DEFLATION DIFFICULTY OCCURRED. THE 90% STENOSED LESION WAS LOCATED IN A MODERATELY TORTUOUS UNKNOWN ARTERY. AFTER STENTING WAS PERFORMED, THE QUANTUM MAV MON 12MM X 2.5MM BALLOON WAS USED FOR POST DILATING. AFTER THE SECOND INFLATION THE BALLOON WOULD NOT DEFLATE. A MINUTE LATER THE BALLOON SLIGHTLY DEFLATED AND WAS ABLE TO BE REMOVED OUTSIDE THE PATIENT'S BODY. 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 H7493808012250 13097222

    Patients

    Seq Age Sex Outcome Treatment
    1 STENT: NOBORI