BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRANETICS LASER SHEATH II

    MDR report key: 2403934 · Received January 5, 2012

    Report

    Report Number
    1721279-2011-00105
    Event Type
    Injury
    Date Received
    January 5, 2012
    Date of Event
    December 7, 2011
    Report Date
    December 7, 2011
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    MFA
    PMA / PMN Number
    P960042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS WAS BILATERAL, CARDIAC LEAD EXTRACTION PERFORMED IN THE O.R. TO EXTRACT 4/6 TOTAL LEADS [(RIGHT SIDE IMPLANTS) SJM 7122 (RV), SJM 2099-52 (RA), SJM EPICARDIAL LEAD (UNKNOWN MODEL #); (LEFT SIDE IMPLANTS) SJM 1688TC (RA), SJM 1580 RIATA (RV), SJM 1056K (LV)] DUE TO A SVC OCCLUSION, NON-FUNCTIONAL LEAD AND CHRONIC PAIN. THE PATIENT WAS PREPPED WITH AN ARTERIAL LEAD, CT SURGEON AND TEE AVAILABLE, AND FLUOROSCOPY IN USE. THE M.D. PREPPED THE LEFT SIDED LEAD 3213 WITH A LLD#2 AND BOTH LV (1056K) AND RV (1580) WITH A LLD-EZ. LASING BEGAN WITH A 16F SLS II ON THE ICD LEAD AND THEN THE LV, SUCCESSFULLY EXTRACTING BOTH. THE RV LEAD WAS LASED WITH THE 16F SLS II AND UPON EXTRACTION OF THIS LEAD A DULL SHADOW ON FLUOROSCOPY WAS NOTED. ALL OTHER PARAMETERS WERE STABLE. THE BEGINNING OF THE EXTRACTION OF THE LAST LEAD (1688TC) FROM THE LEFT SIDE, EASY PASSAGE AT THE BRACHIOCEPHALIC, THE BLOOD PRESSURE BEGAN DROPPING SLOWLY. THE TEE NOTED AN INCREASED SHADOW AND THE DECISION TO PERFORM AN EMERGENT STERNOTOMY WAS MADE WITHIN 2 MINUTES OF THE BLOOD DECLINE. UPON OPENING THE CHEST, AN INJURY TO THE SVC WAS FOUND, REPAIRED AS WELL EXTRACTING THE LAST LEAD. APPROXIMATELY 153 MINUTES LATER, THE PATIENT WAS DECLARED STABLE ENOUGH TO BE TRANSFERRED TO THE ICU FOR RECOVERY. THERE WERE NO DEVICES RETAINED FROM THE PROCEDURE AS THEY WERE REPORTED TO HAVE BEEN DISPOSED OF BY THE O.R. STAFF DURING THE CODE. AN INTERNAL LHR REVIEW SHOWED NO ISSUES OR NON-CONFORMANCES WITH THE LOT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRANETICS LASER SHEATH II 16F SLS II MFA SPECTRANETICS CORP. 500-013 CKK11J12E

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| L| R LLD#2: 518-022| SJM 1580 RIATA ICD LEAD-RETRACTABLE SCREW (RV)| LLD EZ: 518-067| SJM 7122 DURATA (RV)| SJM 1056K QUICKSITE LV IS-1 UNIPOLAR| SJM 1688TC (RA)| SJM EPICARDIAL LEAD: MODEL UNK| SJM 2088-52 (RA)| EXCIMER LASER: CVX-300, SERIAL # (B)(4)