BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE

    MDR report key: 10676088 · Received October 14, 2020

    Report

    Report Number
    2183959-2020-04637
    Event Type
    Injury
    Date Received
    October 14, 2020
    Date of Event
    September 17, 2020
    Report Date
    November 9, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FHW
    PMA / PMN Number
    N970012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ALLEGATION RELATED TO PUMP COLLAPSE WAS REPORTED. THE AMS 700 MOMENTARY SQUEEZE (MS) PUMP WAS VISUALLY INSPECTED. THE KINK RESISTANT TUBING (KRT) WAS WORN TO THE FILAMENT; HOWEVER, NO LEAKS WERE PRESENT. THE PUMP WAS FUNCTIONALLY TESTED AND FAILED THE 8LB. ACTIVATION TEST (2). THE PUMP THEREFORE REQUIRED MORE THAN 8LBS. OF FORCE TO ACTIVATE. HOWEVER, PRODUCT ANALYSIS CONCLUDED THAT IDENTIFIED A PUMP FAILED ACTIVATION TEST WAS THE MOST PROBABLE CAUSE OF THE DEVICE MALFUNCTION. PRODUCT ANALYSIS CONFIRMED PUMP MALFUNCTION. THE PRODUCT RECORD REVIEW INDICATED THAT THE REPORTED EVENTS DO NOT REPRESENT AN UNANTICIPATED EVENT. REVIEW OF THE MANUFACTURING DOCUMENTATION CONFIRMED ALL REQUIRED IN-PROCESS AND FINAL INSPECTIONS AND TESTING WERE COMPLETED. BASED ON THIS INVESTIGATION, THE INVESTIGATION CONCLUSION CODE OF CAUSE TRACED TO COMPONENT FAILURE WAS CHOSEN BECAUSE THE REPORTED EVENTS COULD BE TRACED TO A COMPONENT FAILURE. BASED ON THE RESULTS OF THIS INVESTIGATION, NO ESCALATION IS REQUIRED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED THAT THE PATIENT HAD A REVISION SURGERY SHORTLY AFTER HE REPORTED THAT THE DEVICE WAS NOT WORKING. THE PATIENT HAD TRIED TO ACTIVATE THE DEVICE TO EARLY. THE SURGEON IS WORKING WITH SENIOR COLLEAGUES FOR TROUBLESHOOTING. SAME SYSTEM COMPONENTS: RESERVOIR, MODEL NUMBER: 7210185, LOT NUMBER:1000325339.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING A STICKY INFLATABLE PENILE PROSTHESIS(IPP) PUMP. THE PATIENT HAS NOT USED THE IPP YET AND UPON ACTIVATION THE DEVICE WAS NOT WORKING AND WAS TOO HARD AND STUCK TO USE. THE PATIENT HAD A SURGICAL PROCEDURE TO REVISE THE PUMP AFTER TRYING TO ACTIVATE THE DEVICE TOO EARLY. THERE WERE NO PATIENT COMPLICATIONS RELATED TO THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING A STICKY INFLATABLE PENILE PROSTHESIS(IPP) PUMP. THE PATIENT HAS NOT USED THE IPP YET AND UPON ACTIVATION THE DEVICE WAS NOT WORKING AND WAS TOO HARD AND STUCK TO USE. THE PATIENT HAD A SURGICAL PROCEDURE TO REVISE THE PUMP AFTER TRYING TO ACTIVATE THE DEVICE TOO EARLY. THERE WERE NO PATIENT COMPLICATIONS RELATED TO THIS DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING A STICKY INFLATABLE PENILE PROSTHESIS(IPP) PUMP. THE PATIENT HAS NOT USED THE IPP YET AND UPON ACTIVATION THE DEVICE WAS NOT WORKING AND WAS TOO HARD AND STUCK TO USE. THERE WERE NO PATIENT COMPLICATIONS RELATED TO THIS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1140932 AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE DEVICE IMPOTENCE MECHANICAL/HYDRAULIC FHW BOSTON SCIENTIFIC CORPORATION 72404232 1000330823

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O