BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS INFLATABLE PENILE PROSTHESIS

    MDR report key: 9247874 · Received October 28, 2019

    Report

    Report Number
    2183959-2019-67151
    Event Type
    Injury
    Date Received
    October 28, 2019
    Date of Event
    October 17, 2019
    Report Date
    January 9, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FHW
    UDI-DI
    00878953002712
    PMA / PMN Number
    N970012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT ANALYSIS SUMMARY: PRODUCT ANALYSIS CONFIRMED THE REPORTED ALLEGATION OF A CYLINDER TEAR, WHICH LED TO FLUID LOSS. DHR REVIEW SIMILAR COMPLAINT REVIEW: REVIEW OF MANUFACTURING DOCUMENTATION WAS PERFORMED TO ENSURE THAT ALL REQUIRED INPROCESS AND FINAL INSPECTIONS AND TESTING WERE COMPLETED. REVIEW OF THE MANUFACTURING RECORDS FOR TCF 173577 FOUND NO EVIDENCE THAT THE DEVICE FAILED TO MEET APPLICABLE PRODUCT SPECIFICATIONS PRIOR TO SHIPMENT FROM BOSTON SCIENTIFIC. THERE IS NO EVIDENCE THAT THE REPORTED EVENTS ARE RELATED TO A MANUFACTURING DEFICIENCY BASED ON THE PRODUCT ANALYSIS AND A REVIEW OF THE MANUFACTURING RECORDS. ADDITIONALLY, POTENTIAL EMERGING TRENDS ARE CAPTURED AS PART OF THE POST MARKET SIGNAL EVALUATION AND ESCALATION PROCESS RISK REVIEW- THE AMS 700 HAZARD ANALYSIS INDICATES THAT THE AS REPORTED EVENTS OF THIS COMPLAINT DO NOT REPRESENT A NEW HAZARDOUS SITUATION. ADDITIONALLY, BOSTON SCIENTIFIC DOES NOT HAVE RESPONSIBILITY TO PROVIDE TRAINING TO MEDICAL PROFESSIONAL AS DOCUMENTED IN THE DFU/IFU, AND THE AMS 700 IS NOT A NEW PRODUCT BECAUSE IT IS NOT WITHIN THE FIRST SIX MONTHS OF ITS RELEASE IN ANY GEOGRAPHY, AND IT IS NOT A NEW DESIGN PLATFORM. NO FURTHER REVIEW IS REQUIRED LABELING REVIEW- THERE IS NO OBJECTIVE EVIDENCE THAT THE USER DID NOT PROPERLY HANDLE OR USE THE DEVICE ACCORDING TO THE IFU, AMS700 MS PUMP. ADDITIONALLY, THE REPORTED EVENTS DO NOT CONTAIN AN ALLEGATION AGAINST THE LABELING. NO FURTHER REVIEW IS REQUIRED. SHIPPING REVIEW: SHIPPING REVIEW IS NOT NECESSARY BECAUSE THE LOT NUMBER IS KNOWN. AN ALLEGATION OF FLUID LOSS AND DEVICE MALFUNCTION WERE REPORTED. THE AMS 700 MOMENTARY SQUEEZE (MS) PUMP WAS VISUALLY INSPECTED AND FUNCTIONALLY TESTED; NO LEAKS WERE FOUND. THE PUMP FAILED THE VALVE DEACTIVATE TEST. THE ANALYSIS THEREFORE CONFIRMED A DEVICE MALFUNCTION. IF FURTHER INFORMATION IS RECEIVED AT A LATER DATE, THE PRODUCT INVESTIGATION WILL BE REOPENED TO ADDRESS THE ADDITIONAL INFORMATION. CORRECTION TO H2, H3, AND H6: UPDATED TO INCLUDE DEVICE ANALYSIS. PUMP MODEL- 72404310; LOT SN- (B)(6); MFG DATE- 05/11/2017; EXP DATE- 05/11/2022; GTIN- (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DUE TO A RIGHT CYLINDER TEAR AND DIMPLED PUMP THE PATIENT HAD HIS INFLATABLE PENILE PROSTHESIS (IPP) CYLINDER AND PUMP REMOVED AND REPLACED. THE IPP WAS EXPLANTED AND NEW COMPONENTS CONSISTING OF A 18CMX9.5MM CYLINDER AND PUMP WERE IMPLANTED. IT WAS FURTHER REPORTED THAT THE CYLINDER HAD FLUID LOSS DUE TO THE TEAR AND THE FLUID LOSS OCCURRED TWO WEEKS AHEAD OF THIS SURGERY. THE PATIENT COMPLAINS ABOUT THE LACK OF INFLATION OF CYLINDER. THE PATIENT GOT WELL AFTER THIS SURGERY.

    Additional Manufacturer Narrative · 1

    PUMP MODEL- 72404310, LOT SN- (B)(4), MFG DATE- 05/11/2017, EXP DATE- 05/11/2022, GTIN- (B)(4). DEVICE NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DUE TO A RIGHT CYLINDER TEAR AND DIMPLED PUMP THE PATIENT HAD HIS INFLATABLE PENILE PROSTHESIS (IPP) CYLINDER AND PUMP REMOVED AND REPLACED. THE IPP WAS EXPLANTED AND NEW COMPONENTS CONSISTING OF A 18CMX9.5MM CYLINDER AND PUMP WERE IMPLANTED. IT WAS FURTHER REPORTED THAT THE CYLINDER HAD FLUID LOSS DUE TO THE TEAR AND THE FLUID LOSS OCCURRED TWO WEEKS AHEAD OF THIS SURGERY. THE PATIENT COMPLAINS ABOUT THE LACK OF INFLATION OF CYLINDER. THE PATIENT GOT WELL AFTER THIS SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1038596 AMS INFLATABLE PENILE PROSTHESIS DEVICE IMPOTENCE MECHANICAL/HYDRAULIC FHW BOSTON SCIENTIFIC CORPORATION 72404014 0173577008 00878953002712

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R