BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK²¿

    MDR report key: 2771062 · Received October 3, 2012

    Report

    Report Number
    2134265-2012-05920
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Date of Event
    September 4, 2012
    Report Date
    September 5, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS A COMPLETE SEPARATION OF THE MIDSHAFT 5 MM PROXIMALLY FROM THE GUIDEWIRE EXIT NOTCH. THE APPEARANCE OF THE FRACTURED END OF THE MIDSHAFT MAY BE CONSISTENT WITH SEPARATION DUE TO TENSILE OVERLOAD APPLIED DURING MANIPULATION OF THE DEVICE. MAGNIFIED INSPECTION OF THE FRACTURE SURFACE PRESENTED NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES CONTRIBUTING TO THE SEPARATION. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED PRIOR TO PATIENT CONTACT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING UNPACKING FOR A PERCUTANEOUS CORONARY INTERVENTION, SHAFT BREAK OCCURRED. WHEN PULLING THE 2.5X15MM MAVERICK 2 MONORAIL BALLOON CATHETER OUT OF THE PACKAGE, THE SHAFT BROKE INTO 2 PIECES. THE DEVICE DID NOT ENTER THE PATIENT'S BODY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAVERICK²¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493892815250 15421574

    Patients

    Seq Age Sex Outcome Treatment
    1