BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK²¿

    MDR report key: 3000211 · Received March 12, 2013

    Report

    Report Number
    2134265-2013-01504
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 18, 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: VISUAL INSPECTION OF THE RETURNED DEVICE REVEALED A HYPOTUBE SEPARATION 43.5CM FROM THE EDGE OF THE STRAIN RELIEF. THE HYPOTUBE FRACTURE SURFACES WERE OVALED, WHICH SUGGESTS THE DEVICE WAS KINKED PRIOR TO SEPARATION. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION OF THIS INVESTIGATION 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, SHAFT FRACTURE OCCURRED. THE LESION WAS SITUATED IN THE RIGHT CORONARY ARTERY (RCA). THE ANGIOGRAM SHOWED 90% OF STENOSIS. A MAVERICK 2 BALLOON 2.5X15MM WAS INSERTED TO PRE-DILATE THE LESION. DURING ADVANCEMENT, THE SHAFT FRACTURED. THE DEVICE WAS REMOVED WITH THE GUIDING CATHETER. ANOTHER SAME BALLOON WAS SUCCESSFULLY USED TO COMPLETE THE PROCEDURE. THE PATIENT REMAINED STABLE AND NO COMPLICATION HAS BEEN REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, SHAFT FRACTURE OCCURRED. THE LESION WAS SITUATED IN THE RIGHT CORONARY ARTERY (RCA). THE ANGIOGRAM SHOWED 90% OF STENOSIS. A MAVERICK 2 BALLOON 2.5X15MM WAS INSERTED TO PRE-DILATE THE LESION. DURING ADVANCEMENT, THE SHAFT FRACTURED. THE DEVICE WAS REMOVED WITH THE GUIDING CATHETER. ANOTHER SAME BALLOON WAS SUCCESSFULLY USED TO COMPLETE THE PROCEDURE. THE PATIENT REMAINED STABLE AND NO COMPLICATION HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103787 MAVERICK²¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493892815250 15587033

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR