BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK2 BALLOON CATHETER

    MDR report key: 1801134 · Received August 16, 2010

    Report

    Report Number
    2134265-2010-03503
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Date of Event
    July 21, 2010
    Report Date
    July 21, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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 INTERVENTIONAL (PCI) PROCEDURE, A BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE BRACHIAL ARTERY. THE 75% STENOSED AND DE NOVO LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MODERATELY TORTUOUS PROXIMAL LEFT CIRCUMFLEX (LCX) ARTERY. FOLLOWING ROTATIONAL ATHERECTOMY AND IMPLANT OF A 2.5MM X 18MM PROMUS STENT, THE 20MM X 2.5MM MAVERICK 2 MONORAIL BALLOON CATHETER WAS SELECTED FOR SIDE BRANCH DILATATION. MODERATE RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE MAVERICK 2 BALLOON CATHETER THROUGH THE PROMUS STENT, THE BALLOON RUPTURED AT 12ATMS, ON THE FIRST INFLATION. THE BALLOON CATHETER WAS REMOVED INTACT WITHOUT INCIDENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAVERICK2 BALLOON CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - GALWAY H7493892820250 0013338658

    Patients

    Seq Age Sex Outcome Treatment
    1 INFLATION DEVICE: EVEREST MEDTRONIC| INTRODUCER SHEATH: 6F| GUIDE WIRE: RUNTHROUGH TERUMO| GUIDE CATHETER: HEARTRAIL BL3.5 TERUMO| STENT: PROMUS 2.5-18