BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAFIRE¿ BI-DIRECTIONAL ABLATION CATHETER 4 MM TIP UNIVERSAL TEMPERATURE MONITORI

    MDR report key: 5984154 · Received September 28, 2016

    Report

    Report Number
    3005188751-2016-00071
    Event Type
    Injury
    Date Received
    September 28, 2016
    Date of Event
    August 30, 2016
    Report Date
    August 31, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    LPB
    PMA / PMN Number
    P960016/S014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. OUR INVESTIGATION WAS LIMITED TO THE REVIEW OF THE DEVICE HISTORY RECORD, WHICH SHOWED THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND INDICATED COMPLETE IN ACCORDANCE WITH SJM SPECIFICATIONS AND PROCEDURES. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED AORTIC DISSECTION COULD NOT BE CONCLUSIVELY DETERMINED. PER THE IFU, CARDIAC PERFORATION IS A KNOWN RISK DURING THE USE OF THIS DEVICE.

    Description of Event or Problem · 1

    RELATED MFR REPORT NUMBER: 2030404-2016-00044 AND 3005334138-2016-00054. AN AORTIC DISSECTION OCCURRED DURING AN ABLATION PROCEDURE. A SAFIRE CATHETER WAS USED TO ABLATE THE LEFT VENTRICULAR POSTERIOR LATERAL, HOWEVER IT WAS FELT THE CATHETER WAS NOT ABLATING DEEP ENOUGH AND THE CATHETER WAS REPLACED WITH AN SR0 SHEATH AND A COOL FLEX CATHETER. THE SHEATH WAS INTRODUCED FIRST, BUT IT WAS UNABLE TO ADVANCE TO THE ASCENDING AORTA. THE SHEATH WAS REMOVED AND AN ATTEMPT TO ADVANCE THE COOL FLEX CATHETER WAS DONE WITHOUT SUCCESS. AN AORTIC ANGIOGRAM WAS PERFORMED AND A MINOR AORTIC DISSECTION FROM THE DESCENDING AORTA TO ABDOMINAL AORTA WAS NOTED. THE PATIENT WAS ASYMPTOMATIC AND WAS TRANSFERRED TO THE ICU FOR OBSERVATION. THE DISSECTION RESOLVED WITHOUT INTERVENTION AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE CAUSE FOR THE DISSECTION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636747 SAFIRE¿ BI-DIRECTIONAL ABLATION CATHETER 4 MM TIP UNIVERSAL TEMPERATURE MONITORI CATHETER, PERCUTANEOUS CARDIAC ABLATION LPB ST. JUDE MEDICAL, INC. 402810 5375557

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other FAST CATH SWARTZ SR0 INTRODUCER (B)(4)| THERAPY COOL FLEX ABL CATHETER (B)(4)