BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAFIRE BI-DIRECTIONAL CATH., 7F, LARGE SWEEP, 4MM

    MDR report key: 2230842 · Received August 26, 2011

    Report

    Report Number
    3005188751-2011-00149
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    August 6, 2011
    Report Date
    August 6, 2011
    Manufacturer
    ST. JUDE MEDICAL, AF DIVISION
    Product Code
    LPB
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER WAS NOT RETURNED FOR EVAL. HOWEVER, REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THE DEVICE MET MFG REQUIREMENTS PRIOR TO SHIPMENT. THE ROOT CAUSE CLASSIFICATION FOR THE REPORTED AORTIC DISSECTION IS CONSISTENT WITH ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE IFU.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A LATERAL ACCESSORY PATHWAY CARDIAC ABLATION PROCEDURE THE PT DEVELOPED AN AORTIC DISSECTION. WHILE USING THE SAFIRE BI-DIRECTIONAL ABLATION CATHETER FOR MAPPING AND ABLATING THE LEFT ATRIA VIA RETROGRADE APPROACH, THE PHYSICIAN NOTED THE CATHETER LOOP WOULD NOT OPEN AND THE DEVICE WAS DIFFICULT TO MANEUVER. THE PT COMPLAINED OF ABDOMINAL PAIN DURING THE PROCEDURE BUT THE PT WAS HEMODYNAMICALLY STABLE WITH AN ARTERIAL BLOOD PRESSURE OF 150/70, OXYGEN SATURATION OF 95% ON ROOM AIR WHICH ELEVATED TO 99% WITH OXYGEN THERAPY. THE PT SYMPTOMS PERSISTED AND SELOKEN IV WAS ADMINISTERED. A CT SCAN CONFIRMED AN AORTIC DISSECTION AND THE PT WAS TRANSFERRED EMERGENTLY TO A NEARBY FACILITY FOR SURGERY WITH THE CATHETERS IN PLACE. THE PT UNDERWENT SURGICAL REPAIR AND PROSTHESIS OF THE AORTIC ARCH. CURRENT CONDITION OF THE PT IS IMPROVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFIRE BI-DIRECTIONAL CATH., 7F, LARGE SWEEP, 4MM SAFIRE CATHETER, 7F, LRG LPB ST. JUDE MEDICAL, AF DIVISION 402820 3355188

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention NAVX PATCHES, LOT UNK