BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECLRANET!CS LASER SHEATH II

    MDR report key: 2565317 · Received May 8, 2012

    Report

    Report Number
    1721279-2012-00024
    Event Type
    Malfunction
    Date Received
    May 8, 2012
    Date of Event
    February 6, 2012
    Report Date
    March 13, 2012
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    MFA
    PMA / PMN Number
    P960042
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECLRANET!CS LASER SHEATH II 12 F SLS II MFA SPECTRANETICS CORP. 500-001 CW11J29A

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male CVX-300 EXCIMER LASER, SN (B)(4)| MDT 5076| VISISHEATH, MED 14F