BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK OVER-THE WIRE BALLOON CATHETER

    MDR report key: 813386 · Received January 23, 2007

    Report

    Report Number
    6000093-2007-00165
    Event Type
    Malfunction
    Date Received
    January 23, 2007
    Date of Event
    December 24, 2006
    Report Date
    December 25, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    k934378
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT SOURCE CONFIRMED THAT THE PRODUCT HAD BEEN DISPOSED. THE MANUFACTURING RECORDS FOR TOP ASSEMBLY BATCH 9053098 HAVE BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND. THIS RECORDS REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE OF THE EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PCI PROCEDURE, THE MAVERICK OTW BALLOON RUPTURED. THE LESION WAS LOCATED IN THE CALCIFIED, TORTUOUS, MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE BALLOON RUPTURED BETWEEN 8 TO 10 ATMS ON THE INITIAL INFLATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER MAVERICK OTW 2.0 X 20 MM BALLOON AND THE DEPLOYMENT OF A STENT INSIDE THE PREVIOUSLY PLACED STENT. THERE WERE NO REPORTED PT COMPLICATIONS. PT STATUS LISTED AS "GOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAVERICK OVER-THE WIRE BALLOON CATHETER LOX CATHETERS,TRANSLUMINAL CORONARY ANGIOPLASTY,PERCUTANEOUS LOX BOSTON SCIENTIFIC NA 9053098

    Patients

    Seq Age Sex Outcome Treatment
    1 * GUIDEWIRE: CONQUEST 0.014 ASAHI INTEC| STENT: CYPHER