BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX PTCA DILATATION CATHETER

    MDR report key: 2063396 · Received April 19, 2011

    Report

    Report Number
    2134265-2011-01227
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 18, 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)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION DIFFICULTY REMOVING A BALLOON CATHETER OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE DE NOVO LESION WAS LOCATED IN THE SEVERELY CALCIFIED LEFT CIRCUMFLEX ARTERY (LCX). ROTABLATOR ABLATION OF THE LCX WITH A 1.5MM BURR WAS PERFORMED. THE ROTAWIRE GUIDE WIRE WAS EXCHANGED FOR A NON BSC GUIDE WIRE. THE 15MM X 2.5 NC QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED AND INFLATED THREE TIMES TO 26 ATMS, AND WAS REMOVED SUCCESSFULLY. UPON REINSERTION OF THE NC QUANTUM MAVERICK BALLOON CATHETER RESISTANCE WAS ENCOUNTERED AT THE CORONARY AORTA. THE PHYSICIAN ATTEMPTED TO REMOVE THE BALLOON CATHETER HOWEVER, UPON WITHDRAWAL THE NON BSC GUIDE WIRE WAS ALSO WITHDRAWN. THEREFORE, BOTH DEVICES WERE REMOVED TOGETHER AS ONE UNIT. ONCE REMOVED THE BALLOON CATHETER WAS TESTED WITH A NON BSC GUIDE WIRE AND WAS ABLE TO ADVANCE DISTALLY WITH LITTLE RESISTANCE. SEVERE RESISTANCE WAS ENCOUNTERED WHEN PULLING THE DEVICE PROXIMALLY. THE PROCEDURE WAS COMPLETED WITH THIS 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 NC QUANTUM APEX PTCA DILATATION CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493912415250 14001495

    Patients

    Seq Age Sex Outcome Treatment
    1 BURR, 1.5MM ROTABLATOR BURR CATHETER| GUIDE WIRE, RUNTHROUGH EXTRA FLOPPY