BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM MAVERICK BALLOON CATHETER

    MDR report key: 2003427 · Received March 1, 2011

    Report

    Report Number
    2134265-2011-00373
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 1, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: (B)(6). DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS NOT RECEIVED 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 PROCEDURE, A BALLOON RUPTURE OCCURRED. THE PHYSICIAN WAS TREATING A 90% STENOSED LESION LOCATED IN THE SEVERELY TORTUOUS PROXIMAL TO MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. ANOTHER MANUFACTURERS' 2.5X15MM BALLOON CATHETER WAS USED TO PRE-DILATE THE LESION TO 16ATMS TWICE. TWO GUIDE WIRES WERE THEN ADVANCED USING BUDDY WIRE TECHNIQUE AND ANOTHER MANUFACTURER'S 3.0X24MM STENT WAS IMPLANTED IN THE LESION. AN UNKNOWN MANUFACTURERS' IVUS WAS ATTEMPTED; HOWEVER, IT WAS UNABLE TO CROSS THE LESION. THIS 3.25X8MM QUANTUM MAVERICK BALLOON CATHETER WAS SELECTED FOR POST-DILATION. THE CATHETER CROSSED THE LESION AND UPON THE FIRST INFLATION, THE BALLOON RUPTURED AT 14ATMS AFTER BEING INFLATED FOR 5 SECONDS. POST-DILATION WAS COMPLETED WITH ANOTHER MANUFACTURERS' 3.25X8MM BALLOON CATHETER TO 20ATMS. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUANTUM MAVERICK BALLOON CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493808008320 13501604

    Patients

    Seq Age Sex Outcome Treatment
    1 6F TERUMO INTRODUCER SHEATH| 2.5X15MM IKAZUCHI BALLOON CATHETER| TERUMO RUNTHROUGH HYPERCOAT GUIDE WIRE| 3.0X24MM ENDEAVOR STENT| 6F JL4 LAUNCHER GUIDE CATHETER| EVEREST INFLATION DEVICE