BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RTE SNAPCONE

    MDR report key: 17302191 · Received July 11, 2023

    Report

    Report Number
    2124215-2023-36409
    Event Type
    Malfunction
    Date Received
    July 11, 2023
    Date of Event
    June 22, 2023
    Report Date
    August 11, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FHW
    UDI-DI
    00878953004075
    PMA / PMN Number
    N970012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2B: PRODUCT CODE: FHW/FAE. H4: PREMARKET / 510(K) #: N970012/K090663. UPON RECEIPT AT OUR QUALITY ASSURANCE LABORATORY, THE RETURNED COMPONENT UNDERWENT A THOROUGH ANALYSIS. THE REAR TIP EXTENDERS (RTE) WAS VISUALLY AND MICROSCOPICALLY INSPECTED. NO DAMAGE OR ABNORMALITIES WERE NOTED IN THE RTE. BASED ON THE INFORMATION AVAILABLE AND ANALYSIS RESULTS, THE REPORTED CLINICAL OBSERVATION OF A FOREIGN MATERIAL INSIDE THE STERILE PACKAGING OF THE REAR TIP EXTENDERS (RTE) COULD NOT BE CONFIRMED; THEREFORE, A CONCLUSION CODE OF CAUSE NOT ESTABLISHED WAS ASSIGNED TO THIS INVESTIGATION.

    Additional Manufacturer Narrative · 0

    D2B: PRODUCT CODE: FHW/FAE. H4: PREMARKET / 510(K) #: N970012/K090663.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING THE PREPARATION FOR A PENILE PROSTHESIS PROCEDURE, A FOREIGN MATERIAL INSIDE THE STERILE PACKAGING OF THE REAR TIP EXTENDERS (RTES) WAS DETECTED; THEREFORE, THOSE RTES WERE NOT UTILIZED. OTHER RTES WERE USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING THE PREPARATION FOR A PENILE PROSTHESIS PROCEDURE, A FOREIGN MATERIAL INSIDE THE STERILE PACKAGING OF THE REAR TIP EXTENDERS (RTES) WAS DETECTED; THEREFORE, THOSE RTES WERE NOT UTILIZED. OTHER RTES WERE USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2108455 RTE SNAPCONE PROSTHESIS PENIS INFLATABLE/ PROSTHESIS PENILE FHW BOSTON SCIENTIFIC CORPORATION 72404323 1100294758 00878953004075

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown