BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIAGNOSTIC CATHETER FIXED CURVE WOVEN QUAD

    MDR report key: 3981486 · Received July 25, 2014

    Report

    Report Number
    1222791-2014-00001
    Event Type
    Injury
    Date Received
    July 25, 2014
    Date of Event
    May 23, 2014
    Report Date
    June 25, 2014
    Manufacturer
    BOSTON SCIENTIFIC EP
    Product Code
    DRF
    PMA / PMN Number
    PREAMENDMENT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A MANUFACTURING REVIEW WAS CONDUCTED AND THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. AS NO COMPLAINT SAMPLE OR ADDITIONAL INFORMATION IS AVAILABLE FOR INVESTIGATION THE COMPLAINT IS INCONCLUSIVE.

    Description of Event or Problem · 1

    WE RECEIVED A LETTER FROM (B)(6) REGARDING A COMPLAINT IN A (B)(6) HOSPITAL DURING AN ATRIAL FIBRILLATION PROCEDURE. ACCORDING TO INFORMATION RECEIVED FROM THE DOCTOR, IN THE PROCEDURES WAS INVOLVED ANOTHER CATHETER FROM OTHER COMPANIES. (BOSTON, IASSO WEBSTER, CORDIS AND S. JUDE). THE (B)(6) EVENT DESCRIPTION REPORTED WAS: (B)(4). AFTER AN AFIB ABLATION PROCEDURE, THE PATIENT BLOOD PRESSURE WENT DOWN, THE PHYSICIANS DISCOVERED THE PERFORATION. DURING THE ACTION TO HELP THE PATIENT AND RECOVER THE BLOOD PRESSURE THE PHYSICIANS REALIZED THAT THE PERFORATION WAS AT THE RIGHT ATRIAL, ON THAT CHAMBER WAS NOT USED BW CATHETER. ONLY A BW CATHETER WAS USED, THE ABLATION CATHETER, AND IT WAS USED ONLY AT THE LEFT CHAMBER. AFTER AWHILE IT WAS FINE. THE PROBLEM REPORTED BY THE DOCTOR WAS: IT WAS A LATE PERICARDIAL EFFUSION RESOLVED WITHOUT EXTENDING STAY OF THE PATIENT. THE CAUSE OF THE SPILL IS UNKNOWN AND IT WAS RESOLVED IN THE OPERATING ROOM. THE DOCTOR CONFIRMED THAT THE PATIENT IS GOOD NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436619 DIAGNOSTIC CATHETER FIXED CURVE WOVEN QUAD DRF BOSTON SCIENTIFIC EP 200624S GFYA1315

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention