BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM MAVERICK BALLOON CATHETER

    MDR report key: 2062870 · Received April 19, 2011

    Report

    Report Number
    2134265-2011-01175
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 22, 2011
    Report Date
    March 22, 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

    (B)(4).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

    DESCRIBE EVENT OR PROBLEM: CORRECTION - 14 ATMS CORRECTED TO 12 ATMS AT WHICH BALLOON RUPTURED. (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE 4.0 X 15MM QUANTUM MAVERICK BALLOON CATHETER RUPTURED ON THE FIRST INFLATION AT 12 ATMS (NOT THE 14 ATMS ORIGINALLY REPORTED). 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 90% IN-STENT RESTENOSED LESION WAS LOCATED IN A MODERATELY TORTUOUS WITH NO CALCIFICATION PROXIMAL RIGHT CORONARY ARTERY (RCA). THE 4.0 X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS PLACED ACROSS A NON-BSC STENT AND RUPTURED AT 14 ATMS AFTER AN UNSPECIFIED NUMBER OF INFLATIONS. 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 H7493808015400 11833593

    Patients

    Seq Age Sex Outcome Treatment
    1