BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAFIRE BLU, 1304-CPS-7-25-MC-BD

    MDR report key: 2200838 · Received August 8, 2011

    Report

    Report Number
    2030404-2011-00232
    Event Type
    Injury
    Date Received
    August 8, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 15, 2011
    Manufacturer
    ST. JUDE MEDICAL, IRVINE
    Product Code
    OAD
    PMA / PMN Number
    P060019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONE SAFIRE BLU BI-DIRECTIONAL CATHETER WAS REC'D FOR EVAL. VISUAL INSPECTION REVEALED THE SHAFT TO HAVE A WAVY APPEARANCE THAT DID NOT AFFECT THE FUNCTIONALITY OF THE DEVICE. FUNCTIONAL TESTING OF THE DEVICE CONFIRMED THE CATHETER CREATED A CURVE WHEN DEFLECTED IN BOTH DIRECTIONS AND HELD THE CURVE MATCHING THE REQUIRED TEMPLATE. THE STEERING FORCE MET SPECIFICATION CRITERIA. THE DEVICE PASSED CONTINUITY, RESISTANCE AND EKG TESTING. THE CATHETER ALSO SUCCESSFULLY PASSED THE FLOW RATE, PRESSURE DROP AND ABLATION SIMULATION TEST. THE THERMAL SYSTEM WAS VERIFIED. MICROSCOPIC EVAL OF THE TIP OF THE CATHETER REVEALED NO ANOMALIES. REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THE DEVICE MET MFG REQUIREMENTS PRIOR TO SHIPMENT. THE ROOT CAUSE CLASSIFICATION 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

    SAME EVENT AS MFR NUMBER 2030404-2011-00233. IT WAS REPORTED WHILE USING A SAFIRE BLU BI-DIRECTIONAL CATHETER DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE THE PT DEVELOPED A PERICARDIAL EFFUSION. THE PHYSICIAN INSERTED THE DEVICE INTO THE LEFT ATRIUM USING A 12F NON SJM STEERABLE INTRODUCER. AFTER SEVERAL RADIOFREQUENCY ABLATIONS AROUND THE RIGHT AND LEFT PULMONARY VEINS THE CATHETER WOULD NOT ACHIEVE THE PROPER CURVE. THE CATHETER WAS REMOVED FROM THE PT AND IT WAS NOTED THE DEVICE WOULD NOT MAKE THE PROPER CURVE IN EITHER DIRECTION WHEN DEFLECTED. THE DEVICE WAS REPLACED WITH ANOTHER SAFIRE BLU BI-DIRECTIONAL DEVICE. IMMEDIATELY AFTER INSERTING THE CATHETER INTO THE LEFT ATRIUM THE PHYSICIAN NOTED THE DEVICE WAS DIFFICULT TO MANIPULATE AND WOULD NOT MAKE THE PROPER CURVE IN EITHER DIRECTION. FOLLOWING TWO ABLATIONS WITH THE CATHETER THE PT BECAME HYPOTENSIVE. PREVIOUS EPISODES OF HYPOTENSION HAD OCCURRED DURING THE CASE WHILE ABLATING WITH A NON SJM DEVICE THAT THE PHYSICIAN ATTRIBUTED TO A VAGAL RESPONSE. FOLLOWING THIS INCIDENT THERE WAS NO RISE IN BLOOD PRESSURE AND A PERICARDIAL EFFUSION WAS NOTED. A PERICARDIOCENTESIS WAS PERFORMED AND THE PT STABILIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFIRE BLU, 1304-CPS-7-25-MC-BD CARDIAC ABLATION PERCUTANEOUS CATHETER OAD ST. JUDE MEDICAL, IRVINE A402871 3363411

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention MODEL AND LOT UNK| LOT 3366378| MEDTRONIC ARCTRI FRONT BALLOON| BIOSENSE WEBSTER STEERABLE DECAPOLAR LASSO| MODEL AND LOT UNK| BIOSENSE WEBSTER STEERABLE DECAPOLAR CS CATHETER| CATHETER: MODEL AND LOT UNK| MODEL AND LOT UNK| CATHETER: MODEL AND LOT UNK| SJM MULLEN'S TRANSEPTAL SHEATH: MODEL 406805| BIOSENSE WEBSTER STEERABLE OCTAPOLAR HIS CATHETER| BIOSENSE WEBSTER STEERABLE QUADRAPOLAR HRA| SJM BRK NEEDLE: MODEL 407200, LOT 3401712| MEDTRONIC FEX CATH STEERABLE SHEATH