BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAVERICK2 BALLOON CATHETER

    MDR report key: 2076424 · Received May 4, 2011

    Report

    Report Number
    2134265-2011-01444
    Event Type
    Injury
    Date Received
    May 4, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 5, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER. THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR#: 2134265-2011-01455, 2134265-2011-01456, 2134265-2011-01457. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A VESSEL PERFORATION OCCURRED. ACCESS WAS OBTAINED THROUGH THE RIGHT FEMORAL ARTERY. THE TARGET LESION WAS LOCATED IN THE OBTUSE MARGINAL (OM) OFF OF THE COMPLETELY OCCLUDED LEFT CIRCUMFLEX (LCX). IVUS WAS PERFORMED WITH A NON-BSC IMAGING CATHETER. NEXT, A NON-BSC GUIDE WIRE WAS ADVANCED DOWN THE CX AND A .014X185CM KINETIX GUIDE WIRE WAS ADVANCED DOWN THE OM. A 2.5X10MM NON-BSC BALLOON CATHETER WAS ADVANCED AND INFLATED TO 12 ATMS/60 SEC. A 0.9MMX80 NON-BSC LASER WAS USED IN THE CX AND IVUS WAS PERFORMED AGAIN. NEXT, A 3.0X32MM VERIFLEX STENT DELIVERY SYSTEM WAS ADVANCED TO THE MID OM AND THE STENT WAS DEPLOYED AT 15 ATMS/20 SEC. A 3.0X20MM VERIFLEX SDS WAS ADVANCED TO THE PROXIMAL OM AND DEPLOYED OVERLAPPING THE FIRST STENT. FOR POST-DILATATION, A 3.0X20MM MAVERICK BALLOON CATHETER WAS ADVANCED AND A LARGE PERFORATION WAS OBSERVED. THE MAVERICK BALLOON WAS INFLATED TO 4 ATMS/3 MIN AND 4 ATMS/2 MIN, BUT IT WAS NOT ABLE TO SEAL THE PERFORATION. PERICARDIOCENTESIS WAS PERFORMED AND A TOTAL OF 1850CC OF FLUID WERE REMOVED BEFORE THE PATIENT WAS TAKEN TO OPEN HEART SURGERY. THE PATIENT WAS RELEASED THREE DAYS LATER AND THE STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAVERICK2 BALLOON CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493892820300

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention 2.5X10MM ANGIOSCULPT BALLOON| WHISPER GUIDE WIRE| 3.0X20MM VERIFLEX| 3.0X32 MM VERIFLEX| SPECTRANETICS 0.9MMX80 EXTREME RX LASER| VOLCANO IMAGING CATHETER| KINETIX GUIDE WIRE