BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM MAVERICK BALLOON CATHETER

    MDR report key: 2063150 · Received April 19, 2011

    Report

    Report Number
    2134265-2011-01163
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 22, 2011
    Report Date
    March 23, 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

    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)

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE 3.75 X 20MM QUANTUM MAVERICK BALLOON CATHETER'S FIRST INFLATION WAS TO 12 ATMS. AFTER THE BALLOON RUPTURED, THE BALLOON CATHETER WAS REMOVED FROM THE BODY INTACT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTIONAL PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 100% STENOSED LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY. THE 3.75 X 20MM QUANTUM MAVERICK BALLOON CATHETER WAS INFLATED ONCE WITHOUT INCIDENT. DURING THE SECOND INFLATION AT 16 ATMS, THE BALLOON RUPTURED. 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 QUANTUM MAVERICK BALLOON CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493808020370 12906336

    Patients

    Seq Age Sex Outcome Treatment
    1 ENCORE INFLATION DEVICE| ROUTE GUIDE WIRE| SJM 6FR JR3.5 GUIDE CATHETER| 6FR MEDIKIT INTRODUCER