BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRA-THIN BALLOON DILATATION CATHETER

    MDR report key: 280321 · Received May 31, 2000

    Report

    Report Number
    6000036-2000-00057
    Event Type
    Injury
    Date Received
    May 31, 2000
    Date of Event
    May 5, 2000
    Report Date
    May 5, 2000
    Manufacturer
    MEDI-TECH/A DIVISION OF BOSTON SCIENTIFIC CORP.
    Product Code
    LIT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THIS BALLOON RUPTURED FOLLOWING MULTIPLE INFLATIONS DURING DILATATION OF THE VENOUS AND ARTERIAL ANASTOMOSIS SITES OF AN OCCLUDED ARTERIOVENOUS FISTULA GRAFT. ASPIRATION THROMBECTOMY OF THE VENOUS AND ARTERIAL ANASTOMOSIS SITES WERE PERFORMED PRIOR TO BALLOON DILATATION. FOLLOWING WITHDRAWAL OF THE BALLOON CATHETER, IT WAS NOTED THE BALLOON MATERIAL HAD DETACHED AND REMAINED IN THE PT. A SNARE WAS ADVANCED OVER A GUIDEWIRE AND THE BALLOON MATERIAL WAS SNARED. HOWEVER, MULTIPLE ATTEMPTS TO RETRIEVE THE BALLOON MATERIAL UTILIZING THE SNARE WERE UNSUCCESSFUL AS THE SNARE AND GUIDEWIRE BECAME LODGED WITHIN THE GRAFT. THE PT UNDERWENT SURGICAL RETRIEVAL OF THE BALLOON MATERIAL, SNARE AND GUIDEWIRE AND GRAFT REPAIR. THE PT'S CONDITION IS GOOD AND PT HAS SINCE BEEN DISCHARGED. THE DEVICE IS CURRENTLY BEING EVALUATED BY THIS MFR. UPON COMPLETION OF THE ENGINEERING EVAL, A SUPPLEMENT WILL BE FORWARDED UNDER 6000036-2000-00057. BALLOON RUPTURE OR BALLOON LEAKAGE IS AN ANTICIPATED EVENT OF PERCUTANEOUS ANGIOPLASTY WHICH HAS BEEN ASSOCIATED WITH OVERPRESSURIZATION OR USE IN A CALCIFIED LESION. GRAFT STENOSIS (ANASTOMOTIC AND NON-ANASTOMOTIC) TENDS TO BE MORE DIFFICULT TO OPEN AND USUALLY REQUIRES MUCH HIGHER PRESSURES FOR EFFECTIVE DILATATION THAN DO NATIVE VESSELS. ACCESS TO BYPASS GRAFTS FOR ANGIOPLASTY MAY ALSO CONTRIBUTE TO BALLOON FAILURE. POST-OPERATIVE SCARRING AND/OR LESIONS IN BOTH THE PROXIMAL AND DISTAL ASPECTS OF THE GRAFT MAY NECESSITATE BALLOON MANIPULATION THROUGH PLAQUE OR CALCIFICATION. THE ABOVE FACTORS MAY HAVE CONTRIBUTED TO THIS EVENT. HOWEVER, WITHOUT EVALUATING THE DEVICE, CO IS UNABLE TO DETERMINE THE EXACT CAUSE FOR THIS EVENT AT THIS TIME. DIRECTIONS FOR USE STATE: "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 ULTRA-THIN BALLOON DILATATION CATHETER PTA BALLOON DIL CATHETER LIT MEDI-TECH/A DIVISION OF BOSTON SCIENTIFIC CORP. NA 2379183

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention 8FR MULTIPURPOSE RENAL GUIDING CATHETER,| WHOLEY WIRE, .035" J-WIRE.