BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM? MAVERICK?

    MDR report key: 3132369 · Received May 29, 2013

    Report

    Report Number
    2134265-2013-03712
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 29, 2013
    Report Date
    April 29, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR., EVAL SUMMARY ATTACHED, METHOD CODES, RESULT CODES, CONCLUSION CODES UPDATED. DEVICE EVALUATED BY MFR: THE QUANTUM MAVERICK CATHETER WAS RECEIVED WITH A NON-BSC GUIDEWIRE IN THE WIRE LUMEN. THERE WAS NO DAMAGE TO THE CATHETER. GENTLY PULLING ON THE WIRE, THE WIRE WAS REMOVED FROM THE WIRE LUMEN WITHOUT ENCOUNTERING ANY UNUSUAL RESISTANCE. THE OUTER DIAMETER OF THE WIRE WAS .0137" (MEASURED WITH A CALIBRATED LASER MICROMETER), WHICH IS CONSISTENT WITH A .014" GUIDEWIRE. THE INNER DIAMETER (ID) OF THE WIRE LUMEN WAS MEASURED AT BOTH ENDS WITH A CALIBRATED PIN GAUGE SET; THE ID WAS .014", WHICH IS WITHIN SPECIFICATION. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE WAS NOT CONFIRMED. (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 CATHETER "LOCKED" ON TO GUIDE WIRE OCCURRED. THE TARGET LESION WAS LOCATED IN THE BIFURCATION OF THE LEFT ANTERIOR DESCENDING (LAD) TO THE 1ST DIAGONAL ARTERY. A 12MM X 2.75MM QUANTUM MAVERICK BALLOON CATHETER WAS USED FOR DILATION. THE CATHETER BALLOON FROZE ON A NON-BSC GUIDE WIRE AFTER DEFLATION AND COULD NOT REMOVE THE DEVICE WITHOUT WITHDRAWING THE WHOLE UNIT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, A BALLOON CATHETER "LOCKED" ON TO GUIDE WIRE OCCURRED. THE TARGET LESION WAS LOCATED IN THE BIFURCATION OF THE LEFT ANTERIOR DESCENDING (LAD) TO THE 1ST DIAGONAL ARTERY. A 12MM X 2.75MM QUANTUM MAVERICK BALLOON CATHETER WAS USED FOR DILATION. THE CATHETER BALLOON FROZE ON A NON-BSC GUIDE WIRE AFTER DEFLATION AND COULD NOT REMOVE THE DEVICE WITHOUT WITHDRAWING THE WHOLE UNIT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234822 QUANTUM? MAVERICK? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493808012270 16005828

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR GUIDE WIRE: CORDIS ATW WIRE