BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPECTRANETICS LASER SHEATH II

    MDR report key: 2172682 · Received July 20, 2011

    Report

    Report Number
    1721279-2011-00041
    Event Type
    Death
    Date Received
    July 20, 2011
    Date of Event
    June 23, 2011
    Report Date
    June 23, 2011
    Manufacturer
    SPECTRANETICS CORP.
    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

    DEVICE INVESTIGATIONS PERFORMED BY THE ENGINEERING TEAM ON THE 12F, 14F, 16F SLS II DEVICES AND 12F, 14F, 16F VISISHEATHS. DEVICES WERE NOT PACKAGED ACCORDING TO RETURN PROCEDURE, THEREFORE, ROOT CAUSE OF THE KINKS IN THE SLS DEVICES CANNOT BE DETERMINED. ALL SLS DEVICE'S FIBER OPTIC COUPLERS WERE CUT AND REMOVED PRIOR TO RETURN, THUS SERIAL NUMBERS WERE UNABLE TO BE VERIFIED. NO OTHER MALFORMATIONS OR DAMAGE NOTED TO THE SLS DEVICES. ALL VISISHEATH'S BEVELLED ENDS WERE CUT WITH THE BLUNT ENDS BEING USED AS THE "WORKING END" OF THE DEVICES. AN LHR REVIEW WAS DONE WITH NO NON-CONFORMANCES OR ISSUES NOTED.

    Description of Event or Problem · 1

    THIS WAS A LEFT SIDED, CARDIAC LEAD EXTRACTION PERFORMED IN THE OPERATING ROOM TO REMOVE 2 LEADS (RA & RV - 86 MONTHS OLD) DUE TO AN ACUTE INFECTION. BOTH ARTERIAL LINE PLACED AND ECHOCARDIOGRAM (ECHO) UTILIZED DURING THE CASE. AN UNSUCCESSFUL ATTEMPT WAS MADE TO RETRACT AND SCREWS FROM THE HEART WITH A CLEARING STYLET AND A FRAME. THE MD THEN CHOSE TO ATTACH A LLD-EZ TO EACH LEAD AND BEGAN LASING THE RA LEAD (5076) WITH A 12F SLS II & VISISHEATH. THE 12F SLS II WAS ADVANCED MINIMALLY WHEN THE RA LEAD DETACHED FROM THE HEART WALL. AN ECHO WAS PERFORMED TO RULE OUT AN EFFUSION. THE MD THEN PREPPED A 14F SLS II WITH A VISISHEATH AND BEGAN LASING OVER THE RV LEAD (0158) UNTIL REACHING ADHESIONS AT THE MIDWAY POINT OF THE PROXIMAL COIL. THE MD UPSIZED TO THE 16F SLS II WITH A VISISHEATH WAS ABLE TO PASS THE OBSTRUCTION POINT WITH EASE AND AGAIN THE ECHO WAS CHECKED (PT'S ARTERIAL BP = 124/72). LASING BEGAN AGAIN SLOWLY PROGRESSING DOWN THE PROXIMAL COIL. ECHO WAS ON LIVE VIEW WITH NO EFFUSION NOTED. MD RESUMED LASING UNTIL THE LASER SHEATH WAS PAST THE SVC/ATRIAL JUNCTION. AT THIS POINT, THE PT'S ARTERIAL BP DECREASED TO APPROX 90/50. ECHO WAS AGAIN CHECKED AND A SMALL EFFUSION WAS PRESENT THAT GREW QUICKLY IN SIZE. THE PROCEDURE WAS IMMEDIATELY ABORTED AND RESCUE WAS INITIATED (45SEC TO RESCUE INITIATION FROM ECHO DETERMINATION OF EFFUSION). THE PT WAS PLACED ON BYPASS DURING THE RESCUE. A LARGE TEAR WAS PRESENT THROUGHOUT THE SVC EXTENDING TO THE INNOMINATE VEIN. THE RESCUE CONTINUED FOR APPROXIMATELY 1 HOUR. UNFORTUNATELY, THEY WERE UNABLE TO RESUSCITATE THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRANETICS LASER SHEATH II 16F SLS II MFA SPECTRANETICS CORP. 500-013 CKK11B21G

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death 12F SLS II (B)(4)| 14F SLS II (B)(4)| 16F M (B)(4)| CVX-300 EXCIMER LASER (B)(4)| LLD-EZ (B)(4)| LEAD #0158 & 5076| 14F M (B)(4)| VISISHEATH 12F M (B)(4)