BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRANETICS LEAD LOCKING DEVICE

    MDR report key: 3841666 · Received May 30, 2014

    Report

    Report Number
    1721279-2014-00081
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 12, 2014
    Manufacturer
    SPECTRANETICS CORPORTATION
    Product Code
    DRB
    PMA / PMN Number
    K043401
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    LEAD MANAGEMENT CASE TO EXTRACT TWO ABANDONED LEADS IMPLANTED IN 1990 (1012T RA AND 1026T RV) AND TWO ACTIVE LEADS IMPLANTED IN 1994 (1148T RA AND 1226T RV). THE LOCKING STYLET WAS NOT ABLE TO BE FULLY INSERTED IN THE RA LEADS. THE PHYSICIAN STARTED WITH LASER LEAD EXTRACTION TO GAIN MINIMAL VEIN ACCESS AND THEN SWITCHED TO TIGHTRAIL USING A TECHNIQUE IN ALTERNATING BETWEEN LASER AND TIGHTRAIL AS WELL AS ALTERNATING LEADS THE PHYSICIAN WAS ABLE TO MAKE PROGRESS. AS THE CASE CONTINUED THE PHYSICIAN BEGAN USING THE TIGHTRAIL DEVICE MORE FINALLY EXTRACTING 2 OF THE 4 LEADS (1026T AND THE 1148T). THE PHYSICIAN ATTEMPTED TO USE A COOK EDS SYSTEM BUT DECIDED TO ABANDON THE REMAINDER OF THE LEADS DUE TO THE POTENTIAL OF THEM TO FALL APART; DUE TO THIS ISSUE 2 LLDS WERE ABANDONED. ONE LLD IS REPORTED IN ADVERSE EVENT REPORT NUMBER 1721279-2014-00081 AND ONE IS REPORTED IN ADVERSE EVENT REPORT NUMBER 1721279-2014-00082.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318512 SPECTRANETICS LEAD LOCKING DEVICE LLD #2 DRB SPECTRANETICS CORPORTATION 518-019 FLC14B07A

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other SJM 1026T CARDIAC LEAD (IMPL. 1990)| COOK EDS SYSTEM| SPECTRANETICS 12F GLIDELIGHT LASER SHEATH| SJM 1148T CARDIAC LEAD (IMPL. 1994)| SPECTRANETICS LEAD LOCKING DEVICE #2 X3| SPECTRANETICS 11F TIGHTRAIL SHEATH| SJM 1226T CARDIAC LEAD (IMPL. 1994)| SPECTRANETICS 33CM VISISHEATH X2| SPECTRANETICS 14F GLIDELIGHT LASER SHEATH| SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM| SJM 1012T CARDIAC LEAD (IMPL. 1990)