BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAFESEPT NEEDLE FREE TRANSSEPTAL GUIDEWIRE

    MDR report key: 8190245 · Received December 21, 2018

    Report

    Report Number
    3013986346-2018-00001
    Event Type
    Injury
    Date Received
    December 21, 2018
    Report Date
    December 21, 2018
    Manufacturer
    PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC
    Product Code
    DRC
    UDI-DI
    00858769006111
    PMA / PMN Number
    K172893
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT AVAILABLE FOR EVALUATION. THE DEVICE HISTORY WAS REVIEWED AND FOUND NO ANOMALIES. PROPER MATERIALS AND METHODS OF MANUFACTURING WERE UTILIZED. THERE IS NO INDICATION OF A RELATION BETWEEN THE ADVERSE EVENT AND THE PERFORMANCE OF THE DEVICE. IF ADDITIONAL INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE TRANSSEPTAL PUNCTURE WAS PERFORMED DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE UTILIZING THE SAFESEPT NEEDLE FREE TRANSSEPTAL GUIDEWIRE ALONG WITH A COMPETITOR DILATOR AND INTRODUCER SHEATH TO GAIN ACCESS TO THE LEFT ATRIUM, THE DILATOR PUNCTURED THE LEFT ATRIAL APPENDAGE. AS A RESULT, HEART SURGERY WITH A STERNOTOMY WAS PERFORMED TO CLOSE THE ATRIAL APPENDAGE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1029759 SAFESEPT NEEDLE FREE TRANSSEPTAL GUIDEWIRE NEEDLE FREE TRANSSEPTAL GUIDEWIRE DRC PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC SSNF 000340 00858769006111

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SL1 DILATOR (MANUFACTURED BY ST. JUDE/ABBOTT)