BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM MAVERICK MR BALLOON CATHETER

    MDR report key: 1030613 · Received April 16, 2008

    Report

    Report Number
    2134265-2008-01107
    Event Type
    Malfunction
    Date Received
    April 16, 2008
    Date of Event
    March 17, 2008
    Report Date
    March 18, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LOX
    PMA / PMN Number
    P860019/S167
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, WITHDRAWAL DIFFICULTY AND SHAFT FRACTURE OCCURRED. THE PROCEDURE WAS PERFORMED FOR RECANALIZATION OF A COMPLETE TOTAL OCCLUSION (CTO) OF IN-STENT RESTENOSIS (ISR) IN AN UNKNOWN SIZE/TYPE STENT. THE ISR WAS LOCATED IN THE MILDLY CALCIFIED AND MILDLY TORTUOUS LEFT CIRCUMFLEX (LCX). THE PHYSICIAN HAD DIFFICULTY PASSING AN UNKNOWN TYPE GUIDEWIRE THROUGH THE CTO. THE PHYSICIAN WANTED TO USE THE 12X3.5 MM QUANTUM MAVERICK BALLOON PROXIMAL TO THE CTO TO PROVIDE FURTHER BACKUP FOR THE GUIDEWIRE. AFTER INTRODUCING THE QUANTUM BALLOON INTO THE GUIDING CATHETER THE PHYSICIAN FELT A STRONG RESISTANCE DURING ADJUSTMENT. THE PHYSICIAN TRIED TO PULL THE QUANTUM BALLOON BACK OUT OF THE GUIDING CATHETER. DURING WITHDRAWAL THE QUANTUM BALLOON CATHETER BROKE INSIDE THE GUIDING CATHETER. THE PHYSICIAN PULLED THE QUANTUM BACK OUT OF THE GUIDING CATHETER. THE BALLOON WAS NEVER INFLATED AND ALL PIECES WERE REMOVED FROM THE PATIENT. THE PHYSICIAN CHECKED THE GUIDING CATHETER, AND THERE WAS NO KINKING OBSERVED. THERE WAS NO INJURY TO THE PATIENT AND THE PATIENT CONDITION IS LISTED AS IN WELL CONDITION. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUANTUM MAVERICK MR BALLOON CATHETER LOX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC CORPORATION 12X3.5 MM 9748245

    Patients

    Seq Age Sex Outcome Treatment
    1 OVER 65 CORDIS VISTABRITE 6F XB| 3.5 GUIDE CATHETER