BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XXL BALLOON DILATATION CATHETER

    MDR report key: 253982 · Received December 9, 1999

    Report

    Report Number
    6000036-1999-00151
    Event Type
    Malfunction
    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
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THIS BALLOON RUPTURED AT SIX ATMOSPHERES DURING AN OPEN COMMON ILIAC ANGIOPLASTY OF A CALCIFIED LESION. THE PROCEDURE WAS CANCELLED FOLLOWING BALLOON RUPTURE. ANOTHER BALLOON CATHETER WAS USED PRIOR WHICH ALSO RUPTURED AND COULD NOT BE REMOVED THROUGH THE INTRODUCER SHEATH. THE PT UNDERWENT SURGICAL REMOVAL OF THE BALLOON CATHETER (PLEASE REFERENCE 6000036-1999-00162). FOLLOWING THE UNSUCCESSFUL ANGIOPLASTY ATTEMPTS, THE PT 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 REC'D, EVALUATED AND RETAINED BY THIS MFR. A CIRCUMFERENTIAL TEAR WAS APPROX 22MM PROXIMAL TO THE DISTAL MARKER. THE DISTAL PORTION OF THE BALLOON WAS PARTIALLY INVERTED OVER THE TIP. KINKS WERE NOTED ON THE SHAFT. SCRATCHES WERE PRESENT 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. CO'S FOLLOW UP INDICATED THIS DEVICE WAS USED IN A CALCIFIED LESION. THIS DEVICE DISPLAYED CHARACTERISTICS CONSISTENT WITH CONTACT WITH A SHARP SOURCE, SCRATCHES ON THE BALLOON SURFACE WHICH CO BELIEVES CONTRIBUTED TO THIS EVENT. CO'S 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 THE BALLOON OCCURS DURING INFLATION OR IF BALLOON RUPTURES DURING DILATATION, IMMEDIATELY DISCONTINUE THE PROCEDURE. DEFLATE THE BALLOON. DO NOT REINFLATE AND REMOVE CAREFULLY."

    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 INTRODUCER SHEATH.