BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPECTRANETICS LASER SHEATH

    MDR report key: 1744563 · Received June 30, 2010

    Report

    Report Number
    1721279-2010-00042
    Event Type
    Death
    Date Received
    June 30, 2010
    Date of Event
    January 1, 2005
    Report Date
    June 25, 2010
    Manufacturer
    SPECTRANETICS CORPORATION
    Product Code
    MFA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), NO DEVICES FROM EITHER CASE WERE RETURNED FOR INVESTIGATIVE ANALYSIS, NOR WERE ANY ADDITIONAL CASE DETAILS PROVIDED FOR AN INTERNAL EVALUATION.

    Description of Event or Problem · 1

    THIS IS #3 OF SIX JOURNAL ARTICLES FOUND DURING A ROUTINE CLINICAL LITERATURE REVIEW. TWO DIFFERENT CASES ARE CITED WITHIN THE ARTICLE. JOURNAL: PACE 2006;29:917-920. CASE #1: A PATIENT WITH COMPLETE HEART BLOCK PRESENTED WITH BACTEREMIA, SEPSIS AND PRESUMED ACUTE PACEMAKER INFECTION. 16F SLS WAS USED TO EXTRACT, IN COMPLETE, THE ARTERIAL LEAD WITHOUT COMPLICATION. THE VENTRICULAR LEAD WAS REMOVED WITH SIMPLE TRACTION. A 5 DAY POST-OPERATIVE ECHOCARDIOGRAM REVEALED THE "RIGHT VENTRICULAR" TEMPORARY LEAD WAS IN FACT IN THE LEFT VENTRICLE. A CT OF THE CHEST REVEALED A FISTULA BETWEEN THE LEFT SUBCLAVIAN VEIN AND THE LEFT COMMON ARTERY. CONSIDERING THE PATIENT HAD BEEN ASYMPTOMATIC FOR 11 DAYS, AND WAS CONSIDERED A POOR CANDIDATE FOR OPEN SURGICAL REPAIR, THE DECISION WAS MADE NOT TO REPAIR OR PLACE A COVERED STENT OVER THE FISTULA. PT WAS TREATED WITH ANTIBIOTICS, UNDERWENT THE PLACEMENT OF A RIGHT SUBCLAVIAN PACEMAKER AND REMOVAL OF THE TEMPORARY PACER LEAD WITHOUT PROBLEM. PT WAS DISCHARGED BUT LATER RETURNED WITH COMPLICATIONS AND LATER DIED.

    Additional Manufacturer Narrative · 2

    (B)(4). NO DEVICES FROM EITHER CASE WERE RETURNED FOR INVESTIGATIVE ANALYSIS, NOR WERE ANY ADDITIONAL CASE DETAILS PROVIDED FOR AN INTERNAL EVALUATION.

    Description of Event or Problem · 2

    THIS IS #3 OF SIX JOURNAL ARTICLES FOUND DURING A ROUTINE CLINICAL LITERATURE REVIEW. TWO DIFFERENT CASES ARE CITED WITHIN THE ARTICLE. JOURNAL: PACE 2006;29:917-920. CASE #2: AN (B)(6) FEMALE PATIENT PRESENTING WITH AN ACUTE INFECTION OF HER ICD. MD ATTACHED A LOCKING STYLET TO THE DISTAL END OF THE ATRIAL LEAD. MD BEGAN LASING WITH A 16F SLS AND AFTER ADVANCING ONLY A SHORT DISTANCE, BRIGHT RED BLOOD WAS COMING OUT OF THE PROXIMAL END OF THE SLS. FISTULA WAS IMMEDIATELY SUSPECTED AS THE BLEEDING WAS NOT EASILY CONTROLLED. THE FISTULA WAS OCCLUDED BY A COVERED STENT WITH COMPLETE SUCCESS. VENTRICULAR LEAD WAS MAINTAINED FOR PACING. AFTER APPROPRIATE ANTIBIOTIC THERAPY, A NEW RIGHT-SIDED ICD WAS PLACED AND THE PATIENT DISCHARGED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death| R SPECTRANETICS CVX-300 LASER
    2 80 YR Death| R SPECTRANETICS CVX-300 LASER