BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS INFLATABLE PENILE PROSTHESIS

    MDR report key: 8779047 · Received July 10, 2019

    Report

    Report Number
    2183959-2019-64944
    Event Type
    Injury
    Date Received
    July 10, 2019
    Date of Event
    June 29, 2019
    Report Date
    September 30, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FHW
    UDI-DI
    00878953002705
    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

    CYLINDERS: THE PRODUCT ANALYSIS CONFIRMED THE REPORTED DEVICE ALLEGATION OF A TEAR. THE PRODUCT RECORD REVIEW INDICATED THAT THE PRODUCT MET ALL IN-PROCESS SPECIFICATIONS PRIOR TO LEAVING BSC AND THE REPORTED EVENTS DO NOT REPRESENT A NEW OR UNANTICIPATED EVENT. THE INVESTIGATION CONCLUSION CODE OF CAUSE TRACED TO COMPONENT FAILURE WAS CHOSEN BASED ON THE FACTS THAT THE REPORTED ALLEGATIONS CAN BE TRACED TO A COMPONENT FAILURE IDENTIFIED DURING PRODUCT ANALYSIS. BASED ON THE RESULTS OF THIS INVESTIGATION, NO ESCALATION IS REQUIRED. IF FURTHER INFORMATION IS RECEIVED AT A LATER DATE, THE PRODUCT INVESTIGATION WILL BE REOPENED TO ADDRESS THE ADDITIONAL INFORMATION. PRODUCT ANALYSIS: CYLINDER MALFUNCTION WAS REPORTED. THE AMS700 DEVICE WAS VISUALLY INSPECTED AND FUNCTIONALLY TESTED. THERE WAS A LEAK IN ONE CYLINDER THAT WAS THE RESULT OF INPUT TUBE WEAR AND AVULSION. THIS CYLINDER HAD BROKEN FABRIC THREADS. THE OTHER CYLINDER PERFORMED WITHIN SPECIFICATIONS. THE IDENTIFIED LEAK DUE TO INPUT TUBE WEAR AND AVULSION ARE THE MOST PROBABLE CAUSE FOR THE REPORTED TEAR. BASED ON THE ANALYSIS THE TEAR ALLEGATION CAN BE CONFIRMED. DHR REVIEW: 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 FOR TCF 802315 FOUND NO EVIDENCE THAT THE DEVICE FAILED TO MEET APPLICABLE PRODUCT SPECIFICATIONS PRIOR TO SHIPMENT FROM BSC. RISK REVIEW: NO RISK REVIEW NECESSARY PER WORK INSTRUCTION AS THE AMS 700 HAZARD ANALYSIS (B)(4) INDICATES THAT THE AS REPORTED EVENTS OF THIS COMPLAINT DO NOT REPRESENT A NEW OR UNANTICIPATED HAZARDOUS SITUATION. ADDITIONALLY, BSC 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. LABELING REVIEW: A LABELING REVIEW IS NOT NECESSARY PER WORK INSTRUCTION AS THERE IS NO OBJECTIVE EVIDENCE THAT THE USER DID NOT PROPERLY HANDLE OR USE THE DEVICE ACCORDING TO THE IFU, AMS700 MS PUMP (B)(4) INTENTIONALLY. ADDITIONALLY, THE REPORTED EVENTS DO NOT CONTAIN AN ALLEGATION AGAINST THE LABELING. SHIPPING REVIEW: SHIPPING REVIEW IS NOT REQUIRED PER WORK INSTRUCTION BECAUSE THE LOT NUMBER IS KNOWN. SIMILAR COMPLAINT REVIEW: NO SIMILAR COMPLAINT REVIEW NECESSARY PER WORK INSTRUCTION AS THE INVESTIGATION DOES NOT CONCLUDE THE EVENT IS RELATED TO A MANUFACTURING DEFICIENCY. SYSTEM COMPONENTS: PUMP: MODEL: 72401110 LOT SN: (B)(4), MFG DATE: 03/28/2012, EXP DATE: 03/20/2017. RESERVOIR: MODEL: 72400152, LOT SN: (B)(6), MFG DATE: 03/28/2012, EXP DATE: 03/22/2017.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED THAT THE RIGHT CYLINDER WAS TRIED AND NOT USED BECAUSE ONLY THE LEFT CYLINDER WAS REPLACED AND THERE WAS NO MALFUNCTION REPORTED ON THE RIGHT CYLINDER. THE PATIENT OUTCOME WAS REPORTED TO BE WELL. SYSTEM COMPONENTS PUMP. MODEL-72401110. LOT SN- (B)(6). MFG DATE- (B)(6) 2012. EXP DATE- 03/20/2017. RESERVOIR. MODEL- 72400152. LOT SN- (B)(6). MFG DATE- (B)(6) 2012. EXP DATE- 03/22/2017.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A REPLACEMENT OF AN INFLATABLE PENILE PROSTHESIS(IPP) DEVICE DUE TO A TEAR IN THE LEFT CYLINDER. THE RIGHT CYLINDER WAS TRIED AND NOT USED. A PATIENT OUTCOME WAS NOT REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A REPLACEMENT OF AN INFLATABLE PENILE PROSTHESIS(IPP) DEVICE DUE TO A TEAR IN THE LEFT CYLINDER. THE RIGHT CYLINDER WAS TRIED AND NOT USED. A PATIENT OUTCOME WAS NOT REPORTED.

    Additional Manufacturer Narrative · 1

    SYSTEM COMPONENTS: PUMP: MODEL-72401110, LOT SN- (B)(4), MFG DATE- 03/28/2012, EXP DATE- 03/20/2017. RESERVOIR: MODEL- 72400152, LOT SN- (B)(4), MFG DATE- 03/28/2012, EXP DATE- 03/22/2017.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A REPLACEMENT OF AN INFLATABLE PENILE PROSTHESIS(IPP) DEVICE DUE TO A TEAR IN THE LEFT CYLINDER. THE RIGHT CYLINDER WAS TRIED AND NOT USED. A PATIENT OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572425 AMS INFLATABLE PENILE PROSTHESIS DEVICE IMPOTENCE MECHANICAL/HYDRAULIC FHW BOSTON SCIENTIFIC CORPORATION 72404013 802315004 00878953002705

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| O