BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM MAVERICK BALLOON CATHETER

    MDR report key: 1936038 · Received December 22, 2010

    Report

    Report Number
    2134265-2010-05635
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    December 7, 2010
    Report Date
    December 7, 2010
    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: 18 YEARS OR OLDER. DEVICE EVALUATED BY MANUFACTURER: 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 INTERVENTION PROCEDURE, A BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE PHYSICIAN WAS TREATING A 90% STENOSED LESION LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED, 2.75MM IN DIAMETER, LEFT CIRCUMFLEX (LCX) ARTERY. THIS 2.5X15MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED WITH FORCE TO THE LESION TO PRE-DILATE. THE BALLOON RUPTURED ON THE FIRST INFLATION AT 14ATMS AFTER BEING INFLATED FOR 2 TO 3 SECONDS. THE DEVICE WAS REMOVED FROM THE PATIENT INTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER MANUFACTURERS' BALLOON CATHETER. 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 H7493808015250 13238018

    Patients

    Seq Age Sex Outcome Treatment
    1 BALLOON CATHETER: BP22| INTRODUCER SHEATH: TERUMO OR MEDIKIT