BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX¿

    MDR report key: 2090361 · Received May 16, 2011

    Report

    Report Number
    2134265-2011-01685
    Event Type
    Malfunction
    Date Received
    May 16, 2011
    Date of Event
    April 18, 2011
    Report Date
    February 27, 2012
    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

    DEVICE CODE (B)(4) RELATES TO COMPONENT (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED: NC QUANTUM APEX MONORAIL BALLOON CATHETER INITIALLY REPORTED AS A BALLOON RUPTURE AND CORRECT DEVICE WAS A NON-BSC BALLOON CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE A BALLOON RUPTURE OCCURRED. THE 75% INSTANT RESTENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS MID LEFT ANTERIOR DESCENDING ARTERY (LAD). A 15MM X 3.50MM NC QUANTUM APEX MONORAIL BALLOON CATHETER WAS ADVANCED AND DURING THE FIRST INFLATION TO 13ATMS A BALLOON RUPTURE OCCURRED. THE BALLOON CATHETER WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE DEVICE WAS NOT USED DURING PROCEDURE, BUT A DIFFERENT MANUFACTURER'S BALLOON WAS USED AND A BALLOON RUPTURE OCCURRED WITH THE BALLOON. NOT AS INITIALLY REPORTED THAT A BALLOON RUPTURE OCCURRED WITH THE 15MM X 3.50MM NC QUANTUM APEX MONORAIL BALLOON CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NC QUANTUM APEX¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493912415350

    Patients

    Seq Age Sex Outcome Treatment
    1