BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRANETICS GLIDELIGHT LASER SHEATH

    MDR report key: 3872389 · Received June 13, 2014

    Report

    Report Number
    1721279-2014-00083
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 22, 2014
    Manufacturer
    SPECTRANETICS CORPORATION
    Product Code
    MFA
    PMA / PMN Number
    P960042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THIS CASE HAS BEEN EVALUATED, HOWEVER, RESULTS OF THE INVESTIGATION ARE STILL PENDING. A FOLLOW-UP REPORT WILL BE SENT ONCE THE CONCLUSION OF THE INVESTIGATION HAS BEEN DETERMINED.

    Additional Manufacturer Narrative · 1

    CATHETER INVESTIGATION SUMMARY - THE VISUAL INSPECTION OF THE GLIDELIGHT FOUND THAT APPROXIMATELY 3-5 CM OF THE DISTAL TIP OF THE CATHETER HAD BEEN REMOVED, BUT WAS NOT RETURNED WITH THE REST OF THE DEVICE. THE REMAINING INNER LUMEN WAS CHECKED WITH 0.107 INCH PATENCY MANDREL. THE PATENCY MANDREL WAS DIFFICULT TO SLIDE THROUGH THE LUMEN BUT PASSABLE. THE ID WAS TIGHT FROM THE BIFURCATE THROUGH THE MAJORITY OF THE SHAFT, BUT PASSABLE. THE INNER LUMEN WHEN OPENED DID NOT SHOW ANY INNER LINER DELAMINATION AND THE LHR REVIEW SHOWED THAT THE CATHETER PASSED PATENCY IN PRODUCTION. THE LEAD THAT WAS REMOVED IN THIS CASE HAD A 7F (0.092IN) OD. THIS CATHETER WITH AN ID OF 0.107IN SHOULD HAVE BEEN COMPATIBLE WITH A 7F LEAD UNLESS OTHER MATERIAL WAS PRESENT, HOWEVER THE REPORT FROM THE FIELD WAS THAT THERE WAS NOTHING TO CAUSE ANY BINDING ON THE LEAD. THE INNER LUMEN WAS MARGINAL FROM AN ID PERSPECTIVE BUT FOR THE OD OF THE LEAD THAT THE CATHETER WAS BEING USED FOR SHOULD HAVE PASSED THROUGH EASILY. THE CASE WAS ABLE TO BE COMPLETED BY UPSIZING TO A 14F DEVICE WITH NO ADDITIONAL ISSUES.

    Description of Event or Problem · 1

    DURING A LEAD EXTRACTION PROCEDURE TO REMOVE TWO NON-FUNCTIONAL CARDIAC LEADS, A 12F GLIDELIGHT LASER SHEATH WAS INITIALLY USED, HOWEVER, THE LASER SHEATH GOT STUCK ON THE LEAD AND THE PHYSICIAN HAD TO CUT THE LASER SHEATH TO REMOVE IT FROM THE PATIENT. THE PHYSICIAN UPSIZED TO A 14F GLIDELIGHT AND THE CASE WAS COMPLETED SUCCESSFULLY. NO INJURY OCCURRED TO THE PATIENT AND HE WAS DISCHARGED PER OPERATIVE PLAN. THIS EVENT IS BEING REPORTED BECAUSE OF THE RISK OF INJURY WITH RECURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349412 SPECTRANETICS GLIDELIGHT LASER SHEATH 12F GLIDELIGHT MFA SPECTRANETICS CORPORATION 500-301 FGA13H30A

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other SPECTRANETICS 14F GLIDELIGHT LASER SHEATH| MEDTRONIC 5594 CAPSURE NOVUS SP LEAD (IMPL 84 MON)| MEDTRONIC 6948 SPRINT FIDELIS LEAD (IMPL 84 MON)| COOK ONE TIE COMPRESSION COIL| SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM