BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXABILITY¿ ABLATION CATHETER, BI-D, CURVE D-F

    MDR report key: 5041743 · Received August 31, 2015

    Report

    Report Number
    3008452825-2015-00068
    Event Type
    Injury
    Date Received
    August 31, 2015
    Date of Event
    August 3, 2015
    Report Date
    February 15, 2018
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    OAD
    PMA / PMN Number
    P110016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 PERICARDIAL EFFUSION COULD NOT BE CONCLUSIVELY DETERMINED. PER THE IFU, VASCULAR PERFORATION OR DISSECTION IS AN INHERENT RISK WITH ANY ELECTRODE PLACEMENT.

    Description of Event or Problem · 1

    RELATED MANUFACTURER REPORT 2030404-2015-00064. DURING A REPEAT PULMONARY VEIN ISOLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. AFTER ALL PULMONARY VEINS WERE ISOLATED USING A FLEXIBILITY ABLATION CATHETER, RAPID PACING WAS PERFORMED FROM THE CORONARY SINUS TO ATTEMPT INDUCTION OF ATRIAL FIBRILLATION. THE PATIENT BECAME HYPOTENSIVE AT THIS TIME AND REMAINED HYPOTENSIVE WHEN PACING WAS TERMINATED. AN ECHOCARDIOGRAM REVEALED A PERICARDIAL EFFUSION, FOR WHICH A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THE PATIENT WAS TRANSFERRED TO THE ICU FOR OBSERVATION AND HAS SINCE BEEN DISCHARGED WITH NO FURTHER INTERVENTION. THERE WERE NO PERFORMANCE ISSUES WITH ANY SJM DEVICE.

    Description of Event or Problem · 1

    RELATED MANUFACTURER REFERENCE 2030404-2015-00064, 3008452825-2015-00085, 3005334138-2015-00094, 3005188751-2015-00100, 3005188751-2015-00101, 2030404-2015-00071.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575718 FLEXABILITY¿ ABLATION CATHETER, BI-D, CURVE D-F CARDIAC ABLATION PERCUTANEOUS CATHETER OAD ST. JUDE MEDICAL A701125 4993440

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention