BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK²¿

    MDR report key: 3050716 · Received April 10, 2013

    Report

    Report Number
    2134265-2013-02394
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 13, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS RETURNED IN TWO SECTIONS AS A RESULT OF A BREAK IN THE SHAFT 56.3CM FROM THE STRAIN RELIEF. HYPOTUBE KINKS WERE PRESENT AT VARIOUS LOCATIONS ALONG THE SHAFT. BLOOD WAS PRESENT WITHIN THE BALLOON AND INFLATION LUMEN. THE TIP WAS SLIGHTLY FLARED. THERE WERE NO ISSUES WITH THE BALLOON. 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BIFURCATION TREATMENT PROCEDURE, A SHAFT BREAK OCCURRED. A 20MM X 3.0MM MAVERICK BALLOON CATHETER WAS USED, WHEN IT PASSED BACK THROUGH THE STENT, THE CATHETER SHAFT BROKE. THE DEVICE REMAINED CONTAINED WITHIN THE CATHETER AND RETRIEVE THE DEVICE. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION WAS OK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BIFURCATION TREATMENT PROCEDURE, A SHAFT BREAK OCCURRED. A 20MM X 3.0MM MAVERICK BALLOON CATHETER WAS USED, WHEN IT PASSED BACK THROUGH THE STENT, THE CATHETER SHAFT BROKE. THE DEVICE REMAINED CONTAINED WITHIN THE CATHETER AND RETRIEVE THE DEVICE. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION WAS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152699 MAVERICK²¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - GALWAY H7493892820300 15474904

    Patients

    Seq Age Sex Outcome Treatment
    1