BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRANETICS GLIDELIGHT LASER SHEATH

    MDR report key: 12337761 · Received August 18, 2021

    Report

    Report Number
    1721279-2021-00157
    Event Type
    Injury
    Date Received
    August 18, 2021
    Date of Event
    January 1, 2013
    Report Date
    July 20, 2021
    Manufacturer
    THE SPECTRANETICS CORPORATION
    Product Code
    MFA
    PMA / PMN Number
    P960042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RELATED MDRS: 1721279-2021-00155, 1721279-2021-00156, 1721279-2021-00158, 1721279-2021-00159. THE DEVICE WAS NOT RETURNED FOR EVALUATION, THUS NO INVESTIGATION COULD BE COMPLETED.

    Description of Event or Problem · 1

    A PHILIPS EMPLOYEE BECAME AWARE ON 20 JULY 2021 OF A JOURNAL ARTICLE TITLED "OUTCOMES OF TRANSVENOUS LEAD EXTRACTION USING THE TIGHTRAIL¿ MECHANICAL ROTATING DILATOR SHEATH AND EXCIMER LASER SHEATH" (WILEY, DOI: 10.1111/JCE.15105, ACCEPTED 22 APRIL 2021). IN THE ARTICLE, DATA WAS COLLECTED FROM THE TLE REGISTRY AT ATRIUM HEALTH CAROLINAS MEDICAL CENTER. IT WAS DOCUMENTED THAT FIVE VASCULAR LACERATIONS AND CARDIAC AVULSIONS OCCURRED AND SPECTRANETICS DEVICES WERE IN USE (2 GLIDELIGHT OR SLS, 2 TIGHTRAIL, AND 1 GLIDELIGHT/SLS OR TIGHTRAIL). BECAUSE THE ARTICLE DID NOT A SPECIFY PROCEDURE DATE FOR THE ADVERSE EVENT DESCRIBED, THE PROCEDURE DATE OF 01/01/2013 HAS BEEN POPULATED SINCE THE STUDY INCLUDED DATA FROM 2013-2019. CASE DETAIL, INTERVENTION SPECIFICS (OTHER THAN STERNOTOMY) AND PATIENT OUTCOME CANNOT BE DETERMINED FROM THE DOCUMENTATION AVAILABLE. IT CANNOT BE DETERMINED FROM THE ARTICLE WHETHER A GLIDELIGHT OR SLS LASER SHEATH OR A TIGHTRAIL ROTATING DILATOR SHEATH (BOTH USED IN THE PROCEDURE) WAS SUSPECT AS CAUSING OR CONTRIBUTING TO THE PERFORATION, SO THE MANUFACTURER CHOSE A GLIDELIGHT DEVICE FOR THIS COMPLAINT/ADVERSE EVENT. THE TIGHTRAIL DEVICE USED IN THE PROCEDURE WILL BE LISTED AS A CONCOMITANT DEVICE. ADDITIONAL INFORMATION IS BEING SOUGHT FROM THE AUTHOR. THIS COMPLAINT CAPTURES THE CASE DESCRIBED ABOVE, IN WHICH A GLIDELIGHT (OR SLS) DEVICE WAS IN USE (ALTHOUGH NO ATTRIBUTION TO A SPECIFIC TOOL WAS POSSIBLE) AND A VASCULAR LACERATION AND CARDIAC AVULSION OCCURRED AND REQUIRED INTERVENTION, INCLUDING STERNOTOMY. THERE WAS NO ALLEGED MALFUNCTION OF ANY SPECTRANETICS DEVICES IN USE DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1233280 SPECTRANETICS GLIDELIGHT LASER SHEATH DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS MFA THE SPECTRANETICS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention