BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAVERICK2 MONORAIL PTCA CATHETER

    MDR report key: 1241064 · Received November 20, 2008

    Report

    Report Number
    2134265-2008-04421
    Event Type
    Injury
    Date Received
    November 20, 2008
    Date of Event
    October 23, 2008
    Report Date
    October 23, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    P860019/S179
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INTERVENTIONAL STENTING PROCEDURE, A BALLOON TEAR AND DETACHMENT OCCURRED. THE LESION WAS LOCATED IN THE NON-TORTUOUS RIGHT CORONARY ARTERY. THE LESION WAS NOT CALCIFIED AND THE DEGREE OF STENOSIS IS UNK. THE PHYSICIAN ADVANCED THE MAVERICK 2 MONORAIL 15MM X 2.5MM BALLOON CATHETER TO THE LESION FOR PREDILATION. THE BALLOON WAS INFLATED. THE NUMBER OF INFLATIONS, TIME PER INFLATION, AND ATMS ARE UNK. THE PHYSICIAN WITHDREW THE BALLOON AND REPORTED A TEAR IN THE BALLOON. PART OF THE BALLOON AND RADIOPAQUE MARKER REMAINED INSIDE THE PT. THE PHYSICIAN TRIED TO PLACE AN UNSPECIFIED STENT. THE PHYSICIAN WITHDREW THE STENT AND THE UNSPECIFIED GUIDE WIRE IN AN ATTEMPT TO WITHDRAW THE REMAINDER OF THE BALLOON FROM THE PT. THE PHYSICIAN THEN ADVANCED A STENT AND DEPLOYED IT AND AGAIN ATTEMPTED TO REMOVE THE BALLOON, AS THE TORN PIECE BLOCKED A MAJOR VESSEL. THE PHYSICIAN THEN ADVANCED ANOTHER UNSPECIFIED BALLOON TO ADVANCE THE TORN BALLOON FRACTION FURTHER TO A MORE DISTAL BRANCH. THE TORN BALLOON STILL REMAINS IN THE PT AND IS BLOCKING A SMALLER VESSEL. THE PROCEDURE WAS EXTENDED APPROX 20 MINS, DUE TO THIS EVENT. THE PT REPORTED SLIGHT CHEST PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAVERICK2 MONORAIL PTCA CATHETER LOX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC MAVERICK2 15/2.5 0012007151

    Patients

    Seq Age Sex Outcome Treatment
    1