BEUDAMED
    FDA Adverse Event Death Summary report: N

    FLEXIVA (TM) HIGH POWER SINGLE-USE LASER FIBER

    MDR report key: 4596596 · Received March 12, 2015

    Report

    Report Number
    3005099803-2015-00614
    Event Type
    Death
    Date Received
    March 12, 2015
    Report Date
    February 20, 2015
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    GEX
    PMA / PMN Number
    K100078
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4):THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. SHOULD THE DEVICE BECOME AVAILABLE FOR ANALYSIS AND THERE IS ANY FURTHER RELEVANT INFORMATION, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2015 THAT A FLEXIVA LASER FIBER WAS USED DURING A HOLMIUM LASER ABLATION OF THE PROSTATE (HOLAP) PROCEDURE PERFORMED ON (B)(6), 2015. ACCORDING TO THE COMPLAINANT, THE PROCEDURE LASTED FOR 10 HOURS. REPORTEDLY, THE PATIENT DIED AFTER THE PROCEDURE. ACCORDING TO THE COMPLAINANT, THERE WAS NO MALFUNCTION NOTED TO THE FLEXIVA LASER FIBER DEVICE AND THE FLEXIVA LASER FIBER DID NOT CAUSE THE PATIENT¿S DEATH. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION TO DETERMINE EXACTLY WHEN THE DEATH OCCURRED, WHAT WAS THE CAUSE OF DEATH AND THE CIRCUMSTANCES SURROUNDING THIS EVENT TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2015. ACCORDING TO THE COMPLAINANT, AS OF (B)(6), 2015 THEY DID NOT THINK THAT ANY OF THE EQUIPMENT OR DEVICES USED IN THE CASE CONTRIBUTED TO THE PATIENT¿S DEATH.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2015 THAT A FLEXIVA LASER FIBER WAS USED DURING A HOLMIUM LASER ABLATION OF THE PROSTATE (HOLAP) PROCEDURE PERFORMED ON (B)(6), 2015. ACCORDING TO THE COMPLAINANT, THE PROCEDURE LASTED FOR 10 HOURS. REPORTEDLY, THE PATIENT DIED AFTER THE PROCEDURE. ACCORDING TO THE COMPLAINANT, THERE WAS NO MALFUNCTION NOTED TO THE FLEXIVA LASER FIBER DEVICE AND THE FLEXIVA LASER FIBER DID NOT CAUSE THE PATIENT¿S DEATH. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION TO DETERMINE EXACTLY WHEN THE DEATH OCCURRED, WHAT WAS THE CAUSE OF DEATH AND THE CIRCUMSTANCES SURROUNDING THIS EVENT TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170944 FLEXIVA (TM) HIGH POWER SINGLE-USE LASER FIBER POWERED LASER SURGICAL INSTRUMENT GEX BOSTON SCIENTIFIC - MARLBOROUGH M0068403930

    Patients

    Seq Age Sex Outcome Treatment
    1 Death