BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYMMETRY SMALL VESSEL BALLOON DILATATION CATHETER

    MDR report key: 182334 · Received August 13, 1998

    Report

    Report Number
    6000036-1998-00107
    Event Type
    Injury
    Date Received
    August 13, 1998
    Date of Event
    May 28, 1998
    Report Date
    July 21, 1998
    Manufacturer
    MEDI-TECH A DIVISION 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 THIS BALLOON CATHETER WAS BEING USED TO REPOSITION A STENT IN THE RIGHT ILIAC ARTERY. RESISTANCE WAS ENCOUNTERED DURING WITHDRAWAL OF THE BALLOON CATHETER AND SUBSEQUENT BALLOON DETACHMENT IN THE PT OCCURRED. SUCCESS SURGICAL RETRIEVAL OF THE BALLOON AND STENT FOLLOWED AND A BYPASS PROCEDURE WAS 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. IT WAS INDICATED THIS DEVICE WAS USED IN A NON-INDICATED PROCEDURE, ILIAC STENT PLACEMENT. REPOSITIONING A STENT MAY RESULT IN CONTACT WITH A SURFACE THAT COULD DAMAGE THE BALLOON MATERIAL. CO'S F/U INDICATED THAT THE BALLOON BECAME CAUGHT ON THE STENT DURING WITHDRAWAL AND CONTINUED EXERTION AGAINST RESISTANCE RESULTED IN THE BALLOON DETACHING FROM THE CATHETER SHAFT. CO BELIEVES THESE FACTORS MAY HAVE CONTRIBUTED TO THIS EVENT. HOWEVER, WITHOUT EVALUATING THE DEVICE CO IS UNABLE TO DETERMINE THE EXACT CAUSE FOR THIS EVENT. CO'S DIRECTIONS FOR USE STATE: "MEDI-TECH SYMMETRY AND SYMMETRY STIFF SHAFT BALLOON DILATATION CATHETERS ARE RECOMMENDED FOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY OF SMALL, NARROWED OR OBSTRUCTED ILIAC, FEMORAL OR RENAL VESSELS IN THE PERIPHERAL VASCULATURE. THESE CATHETER ARE NOT DESIGNED FOR USE IN THE CORONARY ARTERIES. ANY USE FOR PROCEDURES OTHER THAN THOSE INDICATED IN THE INSTRUCTIONS IS NOT RECOMMENDED." SAME CASE AS MFR. REPORT # 6000036-1998-00142.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention