BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XXL BALLOON DILATATION CATHETER

    MDR report key: 253124 · Received December 9, 1999

    Report

    Report Number
    6000036-1999-00162
    Event Type
    Injury
    Date Received
    December 9, 1999
    Date of Event
    November 9, 1999
    Report Date
    November 10, 1999
    Manufacturer
    MEDI-TECH A DIVISION OF BOSTON SCIENTIFIC CORP.
    Product Code
    LIT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE BALLOON RUPTURED AT SIX ATMOSPHERES DURING A COMMON ILIAC ANGIOPLASTY OF A CALCIFIED LESION. ATTEMPTS TO REMOVE THE BALLOON CATHETER THROUGH THE SHEATH WERE UNSUCCESSFUL. THE PROXIMAL END OF THE BALLOON CATHETER WAS CUT TO FACILITATE REMOVAL OF THE INTRODUCER SHEATH. THE PT UNDERWENT SURGICAL REMOVAL OF THE BALLOON CATHETER. AN OPEN ANGIOPLASTY WAS ATTEMPTED; HOWEVER, THE BALLOON RUPTURED (PLEASE REFERENCE 6000036-1999-00151). THE PROCEDURE WAS CANCELLED AT THAT TIME. THE PT THEN UNDERWENT REPAIR OF THE ARTERIOTOMY SITE. NO FURTHER DETAILS REGARDING THE PT'S CURRENT STATUS WERE AVAILABLE. HOWEVER, NO PT SEQUELAE RESULTED FROM THIS EVENT. THIS DEVICE WAS RECEIVED, EVALUATED AND RETAINED BY THIS MFR. THE ENGINEERING EVAL INDICATED THE SHAFT WAS CUT 7.3CM PROXIMAL TO THE PROXIMAL RO MARKER. THE SHAFT UNDER THE BALLOON WAS ELONGATED FOR 13MM. A CIRCUMFERENTIAL TEAR WAS NOTED 25MM DISTAL TO THE PROXIMAL RO MARKER. THE DISTAL PORTION OF THE BALLOON WAS PARTIALLY INVERTED. SCRATCHES WERE NOTED ON THE BALLOON SURFACE. BALLOON RUPTURE OR BALLOON LEAKAGE IS AN ANTICIPATED EVENT OF PERCUTANEOUS ANGIOPLASTY WHICH HAS BEEN ASSOCIATED WITH OVERPRESSURIZATION OR USE IN A CALCIFIED LESION. FOLLOW-UP INDICATED THIS DEVICE WAS USED IN A CALCIFIED LESION. THIS DEVICE DISPLAYED CHARACTERISTICS CONSISTENT WITH EXERTION AGAINST RESISTANCE, AN ELONGATED CATHETER SHAFT. THIS DEVICE ALSO DISPLAYED CHARACTERISTICS CONSISTENT WITH CONTACT WITH A SHARP SOURCE, SCRATCHES ON THE BALLOON SURFACE. THE CO BELIEVES THE ABOVE FACTORS CONTRIBUTED TO THIS EVENT. DIRECTIONS FOR USE STATE: "DUE TO THE THIN WALL THICKNESS OF THE XXL BALLOON, XXL BALLOON CATHETERS SHOULD NOT BE USED FOR PROCEDURES INVOLVING HIGHLY CALCIFIED LESIONS OR SYNTHETIC VASCULAR GRAFTS... IF LOSS OF PRESSURE WITHIN BALLOON OCCURS DURING INFLATION OR IF BALLOON RUPTURES DURING DILATATION, IMMEDIATELY DISCONTINUE THE PROCEDURE. DEFLATE THE BALLOON. DO NOT REINFLATE AND REMOVE CAREFULLY... CAUTION: IF RESISTANCE IS FELT WHEN REMOVING A GUIDEWIRE THROUGH A CATHETER OR IF RESISTANCE IS FELT WHEN REMOVING A CATHETER THROUGH AN INTRODUCER SHEATH, STOP AND REMOVE THEM AS A COMPLETE UNIT TO PREVENT DAMAGE TO THE GUIDEWIRE, CATHETER OR VESSEL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XXL BALLOON DILATATION CATHETER PTA BALLOON DIL CATHETER LIT MEDI-TECH A DIVISION OF BOSTON SCIENTIFIC CORP. NA 1680471

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention INTRODUCER SHEATH.