BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM? MAVERICK?

    MDR report key: 3242281 · Received July 23, 2013

    Report

    Report Number
    2134265-2013-04977
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 24, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    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. THERE WAS A COMPLETE SEPARATION OF THE HYPOTUBE. THE HYPOTUBE SEPARATION WAS 18.5 FROM THE STRAIN RELIEF. THE HYPOTUBE FRACTURE SURFACES WERE OVALED, WHICH SUGGESTS THE DEVICE WAS KINKED PRIOR TO SEPARATION. THERE WAS NO EVIDENCE THAT THE SEPARATION WAS ATTRIBUTABLE TO ANY PRODUCT QUALITY DEFICIENCIES. 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, A SHAFT BREAK OCCURRED. THE ECCENTRIC, DE NOVO 90% RESTENOSED TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED AND NON-TORTUOUS LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 190CM X 0.014" NON-BSC GUIDE WIRE WAS USED TO ADVANCE TO THE LESION FOLLOWED BY IMPLANTATION OF UNSPECIFIED STENTS. A 8MM X 4.0MM QUANTUM¿ MAVERICK¿ BALLOON CATHETER WAS SELECTED TO POST-DILATE THE LESION. DURING PUSHING THE BALLOON, THE SHAFT BROKE APPROXIMATELY 20CM AWAY FROM THE HUB. THE DEVICE WAS SUCCESSFULLY WITHDRAWN TOGETHER WITH AN UNSPECIFIED GUIDE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND PATIENT'S CONDITION WAS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, A SHAFT BREAK OCCURRED. THE ECCENTRIC, DE NOVO 90% RESTENOSED TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED AND NON-TORTUOUS LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 190 CM X 0.014" NON-BSC GUIDE WIRE WAS USED TO ADVANCE TO THE LESION FOLLOWED BY IMPLANTATION OF UNSPECIFIED STENTS. A 8 MM X 4.0 MM QUANTUM MAVERICK BALLOON CATHETER WAS SELECTED TO POST-DILATE THE LESION. DURING PUSHING THE BALLOON, THE SHAFT BROKE APPROXIMATELY 20 CM AWAY FROM THE HUB. THE DEVICE WAS SUCCESSFULLY WITHDRAWN TOGETHER WITH AN UNSPECIFIED GUIDE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND PATIENT'S CONDITION WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342894 QUANTUM? MAVERICK? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493808008400 15530069

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR