BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM¿ MAVERICK¿

    MDR report key: 2962001 · Received February 14, 2013

    Report

    Report Number
    2134265-2013-00666
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 17, 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 MANUFACTURER: THE DEVICE WAS RETURNED WITH A COMPLETE SEPARATION OF THE HYPOTUBE 64CM FROM THE EDGE OF 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

    DEVICE IS A COMBINATION PRODUCT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) THE SHAFT BROKE. THE 90% STENOSED ECCENTRIC AND DE NOVO TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MILDLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). THE 4.0X15MM QUANTUM MAVERICK MONORAIL BALLOON CATHETER WAS ADVANCED FOR POST-DILATION, HOWEVER DURING ADVANCEMENT THE SHAFT BROKE ABOUT 60 CM FROM THE HUB. THE BALLOON CATHETER WAS REMOVED WITH THE GUIDE CATHETER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) THE SHAFT BROKE. THE 90% STENOSED ECCENTRIC AND DE NOVO TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MILDLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). THE 4.0 X 15 MM QUANTUM MAVERICK MONORAIL BALLOON CATHETER WAS ADVANCED FOR POST-DILATION, HOWEVER DURING ADVANCEMENT THE SHAFT BROKE ABOUT 60 CM FROM THE HUB. THE BALLOON CATHETER WAS REMOVED WITH THE GUIDE CATHETER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64545 QUANTUM¿ MAVERICK¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493808015400 15156001

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR