BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RTE SNAPCONE

    MDR report key: 11340475 · Received February 17, 2021

    Report

    Report Number
    2183959-2021-00495
    Event Type
    Injury
    Date Received
    February 17, 2021
    Date of Event
    January 29, 2021
    Report Date
    February 17, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FHW
    UDI-DI
    00878953004068
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PREMARKET / 510(K) #: N970012, K090663. PRODUCT INVESTIGATION COMPLETED. AS THE COMPLAINT COMPONENT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT ANALYSIS COULD BE PERFORMED. THE REPORTED ALLEGATIONS COULD NOT BE CONFIRMED. THE EVENT CANNOT BE REPRODUCED OR SUBSTANTIATED; THEREFORE, NO ESCALATION TO NCEP, CAPA OR SCAR IS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE FIRST ATTEMPT TO INTRODUCE THE RIGHT INFLATABLE PENILE PROSTHESIS (IPP) CYLINDER THE 2 CM REAR TIP EXTENDER (RTE) GOT STUCK DUE A TIGHT CORPUS CAVERNOSUM, DETACHED ITSELF FROM THE CYLINDER AND MIGRATED TOWARDS THE CRURA OF THE PENIS. THIS COMPLICATED THE PROCEDURE AS IT TOOK AN HOUR AND A HALF MORE. AFTER SEVERAL ATTEMPTS, THE PHYSICIAN WAS ABLE TO REMOVE THE RTE AND REPLACE IT WITH A 1.5 CM RTE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO FURTHER PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237030 RTE SNAPCONE PROSTHESIS PENIS INFLATABLE/ PROSTHESIS PENILE FHW BOSTON SCIENTIFIC CORPORATION 72404322 1000334012 00878953004068

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R