BEUDAMED
    FDA Adverse Event Death Summary report: N

    LASER PRIME

    MDR report key: 3573 · Received February 16, 1993

    Report

    Report Number
    3573
    Event Type
    Death
    Date Received
    February 16, 1993
    Date of Event
    March 30, 1992
    Report Date
    August 3, 1992
    Manufacturer
    ECLIPSE SURGICAL TECHNOLOGIES, INC.
    Product Code
    LPC
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    A LASER ANGIOPLASTY WAS PERFORMED WITHOUT SUCCESS, AFTER LASER A PTCA BALOON WAS UTILIZED (2.0 LONG SKINNY SCIMED) 2.5 RXP EXTENSION. LAD WAS UNABLE TO BE KEPT OPEN AND PATIENT WAS TREATED MEDICALLY SINCE THE ARTERY WAS TO SMALL TO BE BYPASSED. SEE DICTATED REPORT.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE DISCARDED. THE DEVICE WAS DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LASER PRIME LPC ECLIPSE SURGICAL TECHNOLOGIES, INC. 1.4 LASER PRIME TA-00048-1

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death