BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRANETICS LASER SHEATH II

    MDR report key: 2023160 · Received March 14, 2011

    Report

    Report Number
    1721279-2011-00015
    Event Type
    Injury
    Date Received
    March 14, 2011
    Date of Event
    March 7, 2011
    Report Date
    March 7, 2011
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    MFA
    PMA / PMN Number
    P960042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2011, THE PHYSICIAN REPORTED THAT THE PATIENT "IS AWAKE AND ALERT, EXTUBATED YESTERDAY AND SHOULD MAKE A FULL RECOVERY. THE SVC WAS DISRUPTED ALL ALONG ITS LENGTH, COULD BE SEEN ATTACHED TO THE LEAD. THE SVC WAS PATCHED WITH BOVINE PERICARDIUM. THE INNOMINATE VEIN WAS ALSO DISRUPTED, AS WAS THE L SUBCLAVIAN-LIJ JUNCTION. THESE WERE OVERSEWN BY A VASCULAR SURGEON." ALL SPNC DEVICES USED IN THIS CASE WERE DISPOSED OF DURING THE CODE, THUS BEING UNABLE TO BE RETURNED FOR ENGINEERING ANALYSIS. AN INTERNAL LHR REVIEW REVEALED NO NON-CONFORMANCES OR ISSUES.

    Description of Event or Problem · 1

    THIS WAS A LEFT-SIDED, CARDIAC LEAD REMOVAL CASE THAT TOOK PLACE IN THE EP LAB. THE PATIENT WAS PREPPED WITH AN ARTERIAL LINE AND FLUOROSCOPY WAS ACTIVELY UTILIZED DURING THE CASE. THE MD PREPPED THE FRACTURED, RV LEAD (IMPLANTED (B)(6) 1999) WITH A LLD-EZ AND BEGAN LASING WITH THE 16F SLS II, ANTICIPATING SIGNIFICANT SCARRING AND CALCIUM BUILD UP. APPROXIMATELY 1/4 DOWN THE PROXIMAL COIL LASING BECAME INCREASINGLY DIFFICULT. WITH MINIMAL PRESSURE, THE LASER SHEATH WAS AGAIN ABLE TO ADVANCE. JUST PASS THE PROXIMAL COIL THE PATIENT'S ARTERIAL BLOOD PRESSURE DROPPED FROM A BASELINE OF 103/55 TO 38/28. AT THIS TIME THE CT SURGEON AND THE SURGICAL CARDIAC TEAM WERE PAGED, STAT ECHO, PERICARDIOCENTESIS / THORACOTOMY TRAY AND BLOOD PRODUCTS WERE ORDERED. THE CT SURGEON AND TEAM ARRIVED WITHIN 3 MINUTES OF THE INITIAL PAGE. AT APPROXIMATELY 6 MINUTES, THE SURGEON HAD THE PATIENT'S CHEST OPENED AND DISCOVERED AN APPROXIMATE 1" TEAR IN THE PATIENT'S LATERAL WALL/ATRIAL JUNCTION SVC. THE PATIENT WAS PLACED ON BYPASS AND THE TEAR SUCCESSFULLY REPAIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRANETICS LASER SHEATH II 16F SLS II MFA SPECTRANETICS CORP. 500-013 C10D12E

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Life Threatening| R CVX-300 EXCIMER LASER SYSETM: SERIAL # (B)(4)| LLD-EZ: 518-062, LOT# UNKNOWN