BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRA-THIN BALLOON DILATATION CATHETER

    MDR report key: 182206 · Received August 13, 1998

    Report

    Report Number
    6000036-1998-00142
    Event Type
    Injury
    Date Received
    August 13, 1998
    Date of Event
    May 28, 1998
    Report Date
    August 10, 1998
    Manufacturer
    MEDI-TECH A DIV OF BOSTON SCIENTIFIC CORP.
    Product Code
    LIT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED ANOTHER MFR'S STENT WAS PRE-MOUNTED ON THIS BALLOON CATHETER FOR AN ILIAC STENT PLACEMENT PROCEDURE. DURING DEPLOYMENT OF THE STENT, THE STENT SLID OFF THIS BALLOON INTO THE PT'S ILIAC, RESULTING IN INAPPROPRIATE PLACEMENT PROXIMAL TO THE INTENDED IMPLANT SITE. AN ATTEMPT TO REPOSITION THE STENT WITH ANOTHER BALLOON CATHETER WAS UNSUCCESSFUL AND SUBSEQUENT DETACHMENT OF THAT BALLOON REQUIRED SURGICAL RETRIEVAL OF THE BALLOON AND STENT. A BYPASS PROCEDURE WAS ALSO PERFORMED AT THAT TIME. THE PT'S CONDITION IS GOOD AND HAS SINCE BEEN DISCHARGED. THIS DEVICE HAS BEEN DESTROYED BY THE USER FACILITY. THEREFORE, NO FAILURE ANALYSIS WILL BE AVAILABLE. NO MALFUNCTION OF THE DEVICE WAS NOTED. IT WAS INDICATED THIS DEVICE WAS USED TO EXPAND ANOTHR MFR'S STENT IN THE VASCULATURE. THIS IS A NON-INDICATED USE OF THIS DEVICE. CO'S DIRECTIONS FOR USE STATE: "ULTRA-THIN DIAMOND BALLOON DILATATION CATHETERS ARE RECOMMENDED FOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY OF THE ILIAC, FEMORAL AND RENAL ARTERIES AND FOR THE TREATMENT OF OBSTRUCTIVE LESIONS OF NATIVE OR SYNTHETIC ARTERIOVENOUS DIALYSIS FISTULAE... CERTAIN SIZES OF THE ULTRA-THIN DIAMOND BALLOON DILATATION CATHETER ARE ALSO INDICATED FOR DEPLOYMENT OF THE PALMAZ AND THE PALMAZ-SCHATZ BALLOON-EXPANDABLE STENTS FOR THE BILIARY SYSTEM...ANY USE FOR PROCEDURES OTHER THAN THOSE INDICATED IN THESE INSTRUCTIONS IS NOT RECOMMENDED." SAME CASE AS MFR. REPORT # 6000036-1998-00107

    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 DIV OF BOSTON SCIENTIFIC CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention