BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRANETICS LASER SHEATH II

    MDR report key: 1970123 · Received January 14, 2011

    Report

    Report Number
    1721279-2008-00033
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    April 9, 2008
    Report Date
    April 9, 2008
    Manufacturer
    SPECTRANETICS CORPORATION
    Product Code
    MFA
    PMA / PMN Number
    P960042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER USED IN THE CASE IS NOT AVAILABLE FOR INVESTIGATION. THE PHYSICIAN STATED THAT THE PERFORATION WAS CAUSED BY THE INCREASED STIFFNESS OF THE COMBINED SHEATHS (LASER AND MECHANICAL). THE INCREASED STIFFNESS INDUCED LATERAL FORCE AT THE BRACHIOCEPHALIC CURVE WHEN THEY ATTEMPTED TO NEGOTIATE THE CURVE. THE CURVE HAD PREVIOUSLY AND LATER, WITH THE NEW 16FR SLS, SUCCESSFULLY BEEN NEGOTIATED WITH SINGLE LASER SHEATH TECHNIQUE. HOWEVER, IN THIS CASE, THE OUTER SHEATH WAS NEEDED TO FREE A VERY FIBROTIC VENTRICULAR LEAD TIP.

    Description of Event or Problem · 1

    IN RESPONSE TO FORM 483 ISSUED TO SPECTRANETICS ON (B)(6) 2010, OBSERVATION #2, ALL VIGILANCE REPORTS FILED, WILL ALSO BE FILED WITH THE FDA FOR ALL SAME/LIKE DEVICES SOLD IN THE US. THIS CARDIAC LEAD EXTRACTION INVOLVED THE REMOVAL OF TWO, 15 YR OLD LEADS ABANDONED DUE TO AN ACUTE POCKET INFECTION. THE MD LASED WITH A 16FR SLS SUCCESSFULLY REMOVING THE ATRIAL LEAD. THE MD THEN MOVED TO THE VENTRICULAR LEAD WITH THE SAME 16F SLS. THERE WERE 10+ LASER TRAINS USED IN AN UNSUCCESSFUL ATTEMPT TO FREE THE LEAD. THE SLS WAS REMOVED, RE-CALIBRATED AND ANOTHER 10+ LASER TRAINS WERE USED AND AGAIN HAD DIFFICULTY REMOVING THE LEAD. A NEW 16FR SLS WAS THEN INSERTED AND WITH 10+ LASER TRAINS, THE LEAD WAS SUCCESSFULLY REMOVED. IT WAS AT THIS POINT THE PT'S BLOOD PRESSURE DROPPED, A STERNOTOMY WAS PERFORMED, A PERFORATION WAS FOUND IN THE SVC, AND SUCCESSFULLY REPAIRED. THE PT WAS STABLE POST-OPERATIVELY AND WAS TRANSFERRED TO THE ICU. NO DEVICES WERE RETAINED FOR RETURN DEVICE ANALYSIS, NOR WAS ANY DEVICE LOT/SERIAL NUMBERS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRANETICS LASER SHEATH II 16F SLS II MFA SPECTRANETICS CORPORATION 500-013 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention CVX-300 EXCIMER LASER (B)(4)