BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    SPECTRANETICS 12F GLIDELIGHT LASER SHEATH

    MDR report key: 11869216 · Received May 24, 2021

    Report

    Report Number
    1721279-2021-00094
    Event Type
    Malfunction
    Date Received
    May 24, 2021
    Date of Event
    April 27, 2021
    Report Date
    April 27, 2021
    Manufacturer
    THE SPECTRANETICS CORPORATION
    Product Code
    MFA
    UDI-DI
    00813132020323
    PMA / PMN Number
    P960042
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    B5): THIS EVENT IS NO LONGER REPORTABLE PER THE DEVICE ANALYSIS RESULTS. D9): THE DEVICE WAS RECEIVED BY THE MANUFACTURER ON 29 JUNE 2021. H3): THE DEVICE EVALUATION WAS COMPLETED ON 01 JULY 2021. H6): IN THE INITIAL MDR, HECC CODE 4565 WAS USED, BASED ON THE INFORMATION THE MANUFACTURER RECEIVED IN THE INITIAL COMPLAINT REPORT. HOWEVER, AFTER THE DEVICE EVALUATION AND INVESTIGATION WERE COMPLETED, THIS CODE HAS BEEN CORRECTED TO 4582 (SEE DEVICE EVALUATION BELOW). H6): ADDED CODES 772, 814, 4582, 2199, 10, 3211, AND 67. DEVICE EVALUATION: THE DEVICE WAS RETURNED AND EVALUATED BY A CROSS FUNCTIONAL TEAM ON 01 JULY 2021. A KINK WAS SEEN 11CM FROM DISTAL TIP, NO BREACH OR BROKEN FIBERS WERE SEEN IN THIS AREA. JUST PROXIMAL TO THE DEVICE'S DISTAL MARKER BAND, ONE DEAD FIBER WAS NOTED AND RED LIGHT WAS SEEN SHINING THOUGH THE OUTER JACKET. HOWEVER, THERE WAS NO BREACH TO THE OUTER JACKET IN THIS AREA. ONE DEAD FIBER IS WITHIN THE SPECIFICATION FOR THE DEVICE TO BE RELEASED FOR DISTRIBUTION.

    Description of Event or Problem · 0

    THIS EVENT IS NO LONGER REPORTABLE FOR POTENTIAL EXPOSURE TO MANUFACTURING MATERIALS AND UNINTENDED RADIATION EXPOSURE. PER THE RETURNED DEVICE ANALYSIS, NO BREACH IN THE DEVICE'S OUTER JACKET WAS DETECTED. THIS EVENT DID NOT RESULT IN PATIENT HARM NOR WOULD IT CAUSE OR CONTRIBUTE TO PATIENT HARM WITH RECURRENCE.

    Additional Manufacturer Narrative · 1

    THE COMPONENT AND HEIC CODE FIELDS WERE INTENTIONALLY LEFT BLANK. A SUPPLEMENTAL MDR TO FOLLOW TO ENTER THE APPLICABLE COMPONENT CODE UPON AVAILABILITY (AFTER DEVICE EVALUATION COMPLETE), AND HEIC CODE (B)(4). THE MANUFACTURER IS ANTICIPATING RETURN OF THE DEVICE FOR EVALUATION, BUT HAS NOT RECEIVED IT AT THIS TIME.

    Description of Event or Problem · 1

    DURING PREPARATION FOR A LEAD EXTRACTION PROCEDURE, A SPECTRANETICS 12F GLIDELIGHT LASER SHEATH WAS CALIBRATED FOR USE. HOWEVER, THE PHYSICIAN THEN REALIZED THAT A PORTION OF THE DEVICE'S SHEATH NEAR THE TIP WAS COMPROMISED, AS IT WAS REPORTED THAT LASER LIGHT WAS SHOWING THROUGH. IT WAS REPORTED THAT THE DEVICE WAS NEVER USED IN THE PATIENT AND WAS NOT KINKED. THE PHILIPS REPRESENTATIVE PRESENT IN THE PROCEDURE PLACED THE GLIDELIGHT DEVICE IN A BIOHAZARD BAG FOR RETURN TO THE MANUFACTURER FOR EVALUATION. ANOTHER 12F GLIDELIGHT DEVICE WAS OPENED AND THE PROCEDURE WAS PERFORMED SUCCESSFULLY WITH NO REPORTED PATIENT HARM. THIS EVENT IS BEING REPORTED DUE TO THE POTENTIAL FOR EXPOSURE TO MANUFACTURING MATERIALS AS WELL AS INADVERTENT EXPOSURE TO LASER ENERGY/RADIATION. THE MANUFACTURER IS ANTICIPATING RETURN OF THE DEVICE FOR EVALUATION, BUT HAS NOT RECEIVED IT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769007 SPECTRANETICS 12F GLIDELIGHT LASER SHEATH DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS MFA THE SPECTRANETICS CORPORATION 500-301 FGA20M10A 00813132020323

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other RA PACING LEAD MANUFACTURER UNKNOWN| RV PACING LEAD MANUFACTURER UNKNOWN| SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM| RA PACING LEAD MANUFACTURER UNKNOWN| RV PACING LEAD MANUFACTURER UNKNOWN| SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM