BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXABILITYABLATION CATHETER, UNI-D, CURVE D

    MDR report key: 11783618 · Received May 6, 2021

    Report

    Report Number
    3005334138-2021-00321
    Event Type
    Injury
    Date Received
    May 6, 2021
    Date of Event
    April 28, 2021
    Report Date
    June 3, 2021
    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 · 0

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED EFFUSION REMAINS UNKNOWN. PER THE IFU, VASCULAR PERFORATION IS AN INHERENT RISK OF ANY ELECTRODE PLACEMENT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION REVEALED THE INITIAL MDR FOR THIS EVENT WAS REPORTED UNDER THE INCORRECT MFR REPORT # AND MANUFACTURING SITE. CORRECTED MANUFACTURING SITE INFORMATION HAS BEEN PROVIDED. THE CORRECT MFR NUMBER IS (B)(4).

    Description of Event or Problem · 1

    DURING A LEFT ATRIAL ABLATION PROCEDURE, AN EFFUSION OCCURRED NEAR THE LEFT ATRIUM. APPROXIMATELY THREE HOURS INTO THE PROCEDURE, THE PATIENT BECAME HYPOTENSIVE AND AN ECHOCARDIOGRAM REVEALED AN EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682120 FLEXABILITYABLATION CATHETER, UNI-D, CURVE D CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD ST. JUDE MEDICAL A701157 6467382

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention