BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE

    MDR report key: 8647515 · Received May 28, 2019

    Report

    Report Number
    2183959-2019-63491
    Event Type
    Injury
    Date Received
    May 28, 2019
    Date of Event
    April 23, 2019
    Report Date
    July 12, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FHW
    UDI-DI
    00878953003603
    PMA / PMN Number
    N970012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEW OF MANUFACTURING DOCUMENTATION WAS PERFORMED TO ENSURE THAT ALL REQUIRED IN-PROCESS AND FINAL INSPECTIONS AND TESTING WERE COMPLETED. REVIEW OF THE MANUFACTURING RECORDS ACCORDING TO TCF 931639 FOUND NO EVIDENCE THAT THE DEVICE FAILED TO MEET APPLICABLE PRODUCT SPECIFICATIONS PRIOR TO SHIPMENT FROM BSC. MALFUNCTION WAS REPORTED. THE AMS700 DEVICE WAS VISUALLY INSPECTED AND FUNCTIONALLY TESTED. THERE WAS A LEAK IN ONE-CYLINDER BODY DUE TO SHARP INSTRUMENT DAMAGE CONSISTENT WITH EXPLANT DAMAGE. THE OTHER CYLINDER PERFORMED WITHIN SPECIFICATIONS. THE PUMP WAS NOT FUNCTIONALLY TESTED DUE TO SHARP INSTRUMENT DAMAGE CONSISTENT WITH EXPLANT DAMAGE. BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, THE MOST PROBABLE CAUSE FOR THIS COMPLAINT WAS CONSIDERED UNINTENDED USE ERROR CAUSED OR CONTRIBUTED TO EVENT. THIS COMPLAINT INVESTIGATION CONCLUSION CODE IS UTILIZED FOR THE INTERACTION BETWEEN THE USER AND DEVICE, OR SAMPLE, CAUSED OR CONTRIBUTED TO THE ERROR. THIS INCLUDES UNINTENDED INAPPROPRIATE USE OF THE DEVICE AND INCORRECT SAMPLE PREPARATION. BASED ON THE RESULTS OF THIS INVESTIGATION, NO ESCALATION IS NECESSARY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A DEVICE MALFUNCTION. THE DEVICE STOPPED WORKING AND WAS REMOVED. UPON REMOVAL, AIR WAS IDENTIFIED WITHIN THE PUMP. THE PATIENT OPTED TO HAVE A COLOPLAST TITAN IPP INSERTED. A PATIENT STATUS OF NO ISSUES WAS REPORTED. FURTHER INFORMATION HAS BEEN REQUESTED AND IS NOT YET AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A DEVICE MALFUNCTION. THE DEVICE STOPPED WORKING AND WAS REMOVED. UPON REMOVAL, AIR WAS IDENTIFIED WITHIN THE PUMP. THE PATIENT OPTED TO HAVE A COLOPLAST TITAN IPP INSERTED. A PATIENT STATUS OF NO ISSUES WAS REPORTED. FURTHER INFORMATION HAS BEEN REQUESTED AND IS NOT YET AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438709 AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE DEVICE IMPOTENCE MECHANICAL/HYDRAULIC FHW BOSTON SCIENTIFIC CORPORATION 72404252 931639001 00878953003603

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| O