BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VARI-LASE BRIGHT TIP FIBER

    MDR report key: 3120062 · Received April 29, 2013

    Report

    Report Number
    2134812-2013-00014
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    April 2, 2013
    Manufacturer
    VASCULAR SOLUTIONS, INC.
    Product Code
    GEX
    PMA / PMN Number
    K070216
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A BRIGHT TIP FIBER WAS USED IN A CLINICAL VARI-LASE PROCEDURE. UPON COMPLETION OF TREATMENT, IT WAS OBSERVED THAT THE SHEATH WAS MISSING APPROX 10CM OF THE TIP. THE LASER FIBER REMAINED INTACT WITH NO VISUAL DAMAGE. SCANS CONFIRMED THAT THE SHEATH REMAINED IN THE PT. THE PT WAS RELEASED WITHOUT DEVICE RETRIEVAL AND THE DOCTOR WILL RE-EVALUATE THE PT AGAIN IN 7 TO 10 DAYS. UPON RE-EVAL, THE DOCTOR FOUND THE SHEATH TIP HAD MIGRATED TO THE PT'S ATRIUM, REQUIRING SURGICAL INTERVENTION TO BE REMOVED.

    Description of Event or Problem · 1

    SUMMARY OF EVENT: APPROXIMATELY 10CM OF THE TIP OF A BRIGHT TIP FIBER SHEATH WAS LEFT IN A PATIENT'S LEG FOLLOWING A VARI-LASE PROCEDURE. A FOLLOW-UP EVALUATION FOUND THE SHEATH TIP HAD MIGRATED TO THE PATIENT'S ATRIUM, REQUIRING SURGICAL INTERVENTION TO BE REMOVED. ADDITIONAL INFORMATION: PATIENT REPORTED TO BE DOING WELL AFTER RETRIEVAL AND UPON DISCHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183566 VARI-LASE BRIGHT TIP FIBER POWERED LASER SURGICAL INSTRUMENT GEX VASCULAR SOLUTIONS, INC. 7106 557189

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention