BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK2 BALLOON CATHETER

    MDR report key: 1984127 · Received February 10, 2011

    Report

    Report Number
    2134265-2011-00230
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    January 19, 2011
    Report Date
    January 19, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: RETURNED PRODUCT ANALYSIS REVEALED THE PRODUCT MANDREL WAS INSERTED AND THE BITUBE WAS OVER THE BALLOON. A COMPLETE SEPARATION OF THE HYPOTUBE WAS NOTED 29CM FROM THE MANIFOLD. THE DISTAL SECTION OF THE DEVICE MEASURED 119 CM FROM TIP TO SEPARATION. THE FRACTURED ENDS OF THE HYPOTUBE WERE OVALED, AS IF KINKED PRIOR TO FRACTURING. THERE WAS NO EVIDENCE THAT THE FRACTURE IS ATTRIBUTABLE TO ANY MATERIAL OR MANUFACTURING DEFICIENCIES. 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).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR AN UNSPECIFIED TREATMENT PROCEDURE, A SHAFT BREAK OCCURRED. WHILE PREPARING THE 12MM X 2.0MM MAVERICK 2 BALLOON CATHETER FOR USE, IT WAS NOTED THAT THE DEVICE WAS BROKEN APPROXIMATELY "9 INCHES FROM THE END". THE DEVICE WAS NOT USED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER OF THE SAME DEVICE. AS THE DEVICE DID NOT COME INTO CONTACT WITH THE PATIENT, NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR AN UNSPECIFIED TREATMENT PROCEDURE, A SHAFT BREAK OCCURRED. WHILE PREPARING THE 12MM X 2.0MM MAVERICK 2 BALLOON CATHETER FOR USE, IT WAS NOTED THAT THE DEVICE WAS BROKEN APPROXIMATELY "9 INCHES FROM THE END". THE DEVICE WAS NOT USED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER OF THE SAME DEVICE. AS THE DEVICE DID NOT COME INTO CONTACT WITH THE PATIENT, NO PATIENT COMPLICATIONS WERE REPORTED.

    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 H7493892812200 13389655

    Patients

    Seq Age Sex Outcome Treatment
    1