BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK2 BALLOON CATHETER

    MDR report key: 1941418 · Received December 29, 2010

    Report

    Report Number
    2134265-2010-05729
    Event Type
    Malfunction
    Date Received
    December 29, 2010
    Date of Event
    December 10, 2010
    Report Date
    December 10, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE DEVICE WAS NOT RETURNED TO BSC FOR ANALYSIS. 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 CORONARY INTERVENTION (PCI) PROCEDURE, A BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED THROUGH THE RIGHT FEMORAL ARTERY. THE 90% STENOSED, DE NOVO LESION CONTAINED A 20 DEGREE BEND AND WAS LOCATED IN A HIGHLY CALCIFIED AND MODERATELY TORTUOUS MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE PHYSICIAN ADVANCED THE 2.0MM X 15MM MAVERICK2 BALLOON CATHETER. RESISTANCE WAS NOTED DURING ADVANCEMENT. THE BALLOON WAS INFLATED TO 10ATMS AND AFTER APPROXIMATELY FIVE SECONDS THE BALLOON RUPTURED DUE TO A "CHUNK OF CALCIUM". THE DEVICE WAS REMOVED FROM THE PATIENT INTACT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE. A 2.5MM X 15MM PROMUS STENT WAS IMPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    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 H7493892815200 13836864

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR MEDTRONIC LAUNCHER EBU 3.5 GUIDE CATHETER| 6F INTRODUCER SHEATH| ABBOTT VASCULAR INFLATION DEVICE