BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS INFLATABLE PENILE PROSTHESIS

    MDR report key: 17538052 · Received August 13, 2023

    Report

    Report Number
    2124215-2023-42424
    Event Type
    Injury
    Date Received
    August 13, 2023
    Date of Event
    July 25, 2023
    Report Date
    October 16, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FHW
    UDI-DI
    00878953005720
    PMA / PMN Number
    N970012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT AT OUR QUALITY ASSURANCE LABORATORY, THIS INFLATABLE PENILE PROSTHESIS (IPP) UNDERWENT A THOROUGH ANALYSIS. BOTH CYLINDERS WERE VISUALLY INSPECTED AND UNDERWENT LEAK TESTING. VISUAL INSPECTION FOUND THAT THERE WAS A HOLE ON THE FIRST CYLINDER OUTER TUBE AND KINK RESISTANT TUBING (KRT) CONSISTENT WITH SHARP INSTRUMENT DAMAGE. THE SECOND CYLINDER PASSED VISUAL INSPECTION AND LEAK TESTING. THE PUMP WAS VISUALLY INSPECTED AND UNDERWENT LEAK AND FUNCTIONAL TESTING. THE PUMP PASSED VISUAL INSPECTION AND LEAK TESTING; HOWEVER, IT DID NOT PASS ACTIVATION TESTING. BASED ON THE INFORMATION AVAILABLE AND ANALYSIS RESULTS, THE PUMP ACTIVATION ISSUE COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATION OF MECHANICAL ISSUE; THEREFORE, A CONCLUSION CODE OF CAUSE TRACED TO COMPONENT FAILURE WAS ASSIGNED TO THIS INVESTIGATION.

    Additional Manufacturer Narrative · 0

    PUMP INFORMATION: MODEL NUMBER: 72404301, LOT NUMBER: 1100059743, MODEL/ CATALOG DESCRIPTION: LGX PRECONNECT MS 15CM PS.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PUMP OF THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS MALFUNCTIONING. DURING A REVISION PROCEDURE, A HOLE WAS FOUND IN A CYLINDER. ALL COMPONENTS WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PUMP OF THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS MALFUNCTIONING. DURING A REVISION PROCEDURE, A HOLE WAS FOUND IN A CYLINDER. ALL COMPONENTS WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1354741 AMS INFLATABLE PENILE PROSTHESIS DEVICE IMPOTENCE MECHANICAL/HYDRAULIC FHW BOSTON SCIENTIFIC CORPORATION 72404301 1100059743 00878953005720

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Hospitalization| R RESERVOIR: UPN: 72404161 / LOT: 1100088375| RESERVOIR: UPN: 72404161 / LOT: 1100088375