BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK2 BALLOON CATHETER

    MDR report key: 1970873 · Received January 26, 2011

    Report

    Report Number
    2134265-2011-00097
    Event Type
    Malfunction
    Date Received
    January 26, 2011
    Date of Event
    January 4, 2011
    Report Date
    January 5, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE RETURNED DEVICE WAS RECEIVED IN TWO PIECES. THE SHAFT OF THE DEVICE WAS BROKEN 1" PROXIMAL TO THE GUIDE WIRE EXIT NOTCH. MICROSCOPIC INSPECTION OF THE DISTAL PORTION REVEALED A KINK ON THE GUIDE WIRE EXIT NOTCH AND THE SHAFT WAS STRETCHED. THE INNER SHAFT, LOCATED INSIDE THE BALLOON, WAS ACCORDIONED FROM THE PROXIMAL WELD EXTENDING THROUGH THE TIP. THE ENTIRE LENGTH OF THE BALLOON WAS BUNCHED UP. 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 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, A SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT MAIN. A CHOICE PT GUIDE WIRE WAS PLACED ACROSS THE LESION. WHILE ATTEMPTING TO ADVANCE THE 25MM X 2.5MM MAVERICK2 BALLOON CATHETER OVER THE WIRE, THE SHAFT BROKE AT THE WIRE EXIT JUNCTION, WHILE REMAINING EXTERNAL TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER MAVERICK BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS OK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, A SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT MAIN. A CHOICE PT GUIDE WIRE WAS PLACED ACROSS THE LESION. WHILE ATTEMPTING TO ADVANCE THE 25MM X 2.5MM MAVERICK2 BALLOON CATHETER OVER THE WIRE, THE SHAFT BROKE AT THE WIRE EXIT JUNCTION, WHILE REMAINING EXTERNAL TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER MAVERICK BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAVERICK2 BALLOON CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493892825250 13689903

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR CHOICE PT GUIDE WIRE