BEUDAMED
    FDA Adverse Event Other Summary report: N

    EXCIMER LASER ATHERECTOMY CATHETERS

    MDR report key: 2548144 · Received December 19, 2008

    Report

    Report Number
    1721279-2008-00025
    Event Type
    Other
    Date Received
    December 19, 2008
    Date of Event
    December 16, 2008
    Report Date
    December 16, 2008
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    LPC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS: THERE WERE NO DEVICES RETURNED TO SPECTRANETICS (SPNC) FOR FAILURE ANALYSIS. THE SPNC REP SPOKE WITH THE PHYSICIAN AND HIS FELLOW AFTER THE PROCEDURE. THEY BOTH AGREED THE SPNC DEVICE DID NOT CAUSE THE EVENT. PATIENT HAD A SIMILAR EPISODE ON FLOOR THE PRIOR EVENING, SO HE WAS OBVIOUSLY UNSTABLE PRIOR TO CATH PROCEDURE.

    Description of Event or Problem · 1

    INDICATIONS FOR PROCEDURE. THE 90 PERCENT + LESION IN AN SVG TO THE OM TO PDA. PROCEDURE: THROMBUS WAS VISUALIZED PROXIMAL TO LESION AND THE DECISION WAS MADE TO PUT IN A DISTAL PROTECTION DEVICE AND THEN LASER TO CLEAR SOME OF THE THROMBUS PRIOR TO STENTING AND BALLOONING. ACCESS WAS MADE, CATHETER SEATED, WIRE DOWN AND DISTAL PROTECTION DEVICE PLACED ALL WITHOUT ANY ISSUES. FIRST TWO PASSES WITH LASER AT 40 / 40 WERE MADE WITH NO ISSUES. TURNED LASER UP TO 60 / 60 FOR THIRD PASS WHICH WAS MADE FORWARD AND BACKWARDS. THIS IS WHEN PATIENT WENT BRADYCARDIC AND THEN ASYSTOLE. MULTIPLE ATTEMPTS WERE MADE TO EXTERNALLY PACE AND PROPER DRUGS GIVEN, BUT WITH NO SUCCESS. COMPRESSIONS WERE GIVEN UNTIL TEMPORARY PACER COULD BE INSERTED VIA GROIN. AT ONE POINT, AN ANGIO WAS SHOT SHOWING THE ENTIRE GRAFT WAS DOWN. DISTAL PROTECTION REMOVED AND ASPIRATION CATHETER WAS USED WITH VERY LITTLE THROMBUS PRESENT. A VENTILATOR AND BALLOON PUMP WAS ALSO PLACED TO STABILIZE PATIENT. PATIENT OUTCOME: THE PATIENT SURVIVED THE INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCIMER LASER ATHERECTOMY CATHETERS ELCA LPC SPECTRANETICS CORP. 110-004 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention SPECTRANETICS CVX-300 LASER