BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFESEPT NEEDLE FREE TRANSSEPTAL GUIDEWIRE

    MDR report key: 8977712 · Received September 9, 2019

    Report

    Report Number
    3013986346-2019-00001
    Event Type
    Malfunction
    Date Received
    September 9, 2019
    Date of Event
    May 29, 2019
    Manufacturer
    PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC
    Product Code
    DRC
    UDI-DI
    00858769006111
    PMA / PMN Number
    K172893
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS TO INDICATE WHY THIS SUBMISSION WAS SUBMITTED PAST THE 30-DAY MARK. THE INFORMATION IN THIS SUBMISSION WAS SUBMITTED ON 27JUN2019. THE ACKNOWLEDGEMENT LETTERS WERE RECEIVED AND STATED "DELIVERED"; HOWEVER, THESE LETTERS WERE NOT DOWNLOADED TO CONFIRM SUCCESSFUL DELIVERY. THE FDA WAS CONTACTED ON 6SEP2019 TO UNDERSTAND WHY THE SUBMISSION WAS NOT ON MAUDE, AND THE PROCESS OF REVIEWING THE ACKNOWLEDGEMENT LETTERS WAS EXPLAINED. THE ORIGINAL SUBMISSION HAD A DELIVERY FAILURE DUE TO EXCESS CHARACTERS IN FIELD D11. THEREFORE, THE REPORT WAS SUBMITTED AGAIN ON 9SEP2019 AFTER THE ISSUE WAS CORRECTED, AND SUCCESSFUL DELIVERY WAS CONFIRMED.

    Description of Event or Problem · 0

    THIS WAS A DOUBLE TRANSSEPTAL PROCEDURE. THE WIRE CROSSED WITHOUT ANY ISSUES. THE PHYSICIAN WAS UNABLE TO CROSS THE SEPTUM WITH THE SHEATH. THE WIRE, DILATOR, AND CANNULA WERE REMOVED, LEAVING THE SHEATH IN THE RIGHT ATRIUM. WHEN REMOVING THE WIRE INTO THE DISPENSER, IT WAS NOTICED THAT THE DISTAL "J" PORTION OF THE WIRE WAS MISSING. IMAGING WAS USED AND FOUND THAT THE "J" PORTION OF THE WIRE REMAINED IN THE PATIENT.

    Additional Manufacturer Narrative · 1

    A PROCEDURE WAS PERFORMED USING THE SAFESEPT NEEDLE FREE (SSNF). WHEN REMOVING THE WIRE INTO THE DISPENSER, IT WAS NOTICED THAT THE DISTAL "J" PORTION OF THE WIRE WAS MISSING. THE DEVICE HISTORY WAS REVIEWED AND FOUND NO ANOMALIES. PROPER MATERIALS AND METHODS OF MANUFACTURING WERE UTILIZED. SCANNING ELECTRON MICROSCOPY (SEM) WAS USED TO ANALYZE THE FRACTURED WIRE AND CONCLUDED THAT THE FAILURE APPEARS TO BE DUE TO AN OVERSTRESS EVENT CAUSED BY A SHEAR FORCE THAT WAS TOO STRONG FOR THE WIRE ALLOY. IF ADDITIONAL INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THIS WAS A DOUBLE TRANSSEPTAL PROCEDURE. THE WIRE CROSSED WITHOUT ANY ISSUES. THE PHYSICIAN WAS UNABLE TO CROSS THE SEPTUM WITH THE SHEATH. THE WIRE, DILATOR, AND CANNULA WERE REMOVED, LEAVING THE SHEATH IN THE RIGHT ATRIUM. WHEN REMOVING THE WIRE INTO THE DISPENSER, IT WAS NOTICED THAT THE DISTAL "J" PORTION OF THE WIRE WAS MISSING. IMAGING WAS USED AND FOUND THAT THE "J" PORTION OF THE WIRE REMAINED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770167 SAFESEPT NEEDLE FREE TRANSSEPTAL GUIDEWIRE NEEDLE FREE TRANSSEPTAL GUIDEWIRE DRC PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC SSNF 000529 00858769006111

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization TSC171 CANNULA, SJM AGILIS, AND SL0 INTRODUCER| TSC171 CANNULA, SJM AGILIS, AND SL0 INTRODUCER