BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLUE MAX BALLOON DILATATION CATHETER

    MDR report key: 232455 · Received July 20, 1999

    Report

    Report Number
    6000036-1999-00106
    Event Type
    Injury
    Date Received
    July 20, 1999
    Date of Event
    June 22, 1999
    Report Date
    June 22, 1999
    Manufacturer
    MEDI-TECH A DIV OF BOSTON SCIENTIFIC CORP.
    Product Code
    LIT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED FOLLOWING THE RUPTURE OF ANOTHER BALLOON, THIS BALLOON RUPTURED AT 10 ATMOSPHERES, AFTER THE FIRST INFLATION, DURING AN ILIAC ANGIOPLASTY PROCEDURE OF A STENOTIC AND BRITTLE ARTERY. THE PHYSICIAN DETERMINED ADEQUATE DILATATION WAS ACHIEVED AND A THIRD BALLOON WAS NOT USED. A COMPLETION ANGIOGRAM WAS DONE AND SLIGHT EXTRAVASATION OUT OF THE ARTERY WAS NOTED, HOWEVER, NO TREATMENT WAS ADMINISTERED. A SCHEDULED FEMORAL-POPLITEAL BY-PASS PROCEDURE WAS THEN SUCCESSFULLY PERFORMED. THREE TO FOUR HOURS POST BY-PASS PROCEDURE IT WAS NOTICED THE PATIENT'D BLOOD PRESSURE WAS DROPPING. FOUR UNITS OF BLOOD AND 2 UNITS OF PLASMA WERE ADMINISTERED. LATER THAT EVENING, A PATCH ANGIOPLASTY PROCEDURE WAS PERFORMED TO SUCCESSFULLY REPAIR THE ARTERY. THE PATIENT'S CONDITION IS GOOD. THIS DEVICE WAS DESTOYED BY THE USER FACILITY. THEREFORE, NO FAILURE ANALYSIS WILL BE AVAILABLE. BALLOON RUPTURE OR BALLOON LEAKAGE IS AN ANTICIPATED EVENT OF PERCUTANEOUS ANGIOPLASTY WHICH HAS BEEN ASSOCIATED WITH OVERPRESSURIZATION OR USE IN A CALCIFIED LESION. CO'S FOLLOW UP REVEALED THE ARTERY WAS STENOTIC AND BRITTLE WHICH CO FEELS MAY HAVE CONTRIBUTED TO THIS EVENT. HOWEVER, CO IS UNABLE TO DETERMINE THE EXACT CAUSE OF THIS EVENT. CO'S DIRECTIONS OF USE STATE: "THE MINIMAL DILATING FORCE REQUIRED TO DILATE SHOULD BE APPLIED, MINIMIZING THE RISKS OF BALLOON OVER-INFLATION OR RUPTURE... IF LOSS OF PRESSURE WITHIN THE BALLOON OCCURS DURING INFLATION OR IF BALLOON RUPTURES DURING DILATATION, IMMEDIATELY DISCONTINUE THE PROCEDURE. DEFLATE THE BALLOON. DO NOT REINFLATE AND REMOVE CAREFULLY". SAME CASE AS MFR. REPORT# 6000036-1999-00105.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLUE MAX BALLOON DILATATION CATHETER PTA BALLOON DIL CATHETER LIT MEDI-TECH A DIV OF BOSTON SCIENTIFIC CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention