BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TACTRA MALLEABLE PENILE PROTHESIS

    MDR report key: 9417485 · Received December 5, 2019

    Report

    Report Number
    2183959-2019-67854
    Event Type
    Injury
    Date Received
    December 5, 2019
    Date of Event
    November 21, 2019
    Report Date
    December 11, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FAE
    UDI-DI
    08714729979357
    PMA / PMN Number
    K183619
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT INVESTIGATION: THE COMPLAINT COMPONENT WAS NOT RETURNED FOR ANALYSIS, AND THE PRODUCT RECORD REVIEW REVEALED NO ADDITIONAL INFORMATION RELATED TO THE COMPLAINT SO AN OVERALL INVESTIGATION CONCLUSION CODE OF CAUSE NOT ESTABLISHED WAS CHOSEN AS THE REPORTED DEVICE PROBLEM CANNOT BE CONFIRMED. THE REPORTED ALLEGATIONS COULD NOT BE CONFIRMED. THE EVENT CANNOT BE REPRODUCED OR SUBSTANTIATED; THEREFORE, NO ESCALATION TO IS REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING IMPLANT OF THIS TACTRA MALLEABLE PENILE PROSTHESIS, A CROSS-OVER OCCURRED DURING DILATION OF THE CORPORA RESULTING IN A PERFORATION ON THE RIGHT SIDE. THE RIGHT CYLINDER WAS REMOVED WHILE THE LEFT CYLINDER REMAINED IMPLANTED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE CROSSOVER AND PERFORATION WERE IDENTIFIED VISUALLY; IT WAS NOTED TO BE VERY APPARENT AS THE PENIS WAS VERY CROOKED. IT WAS FURTHER REPORTED THE PERFORATION OCCURRED DISTALLY AFTER WHICH THE PHYSICIAN ELECTED TO KEEP A CATHETER PLACED IN THE PATIENT AS WELL AS THE LEFT CYLINDER IN ORDER TO PRESERVE SPACE. THE PATIENT REMAINS UNDER THE PHYSICIAN'S CARE. NO FURTHER DETAILS WERE PROVIDED. FURTHER DETAILS WERE PROVIDED INDICATING THE DILATORS USED FOR THE PROCEDURE WERE FROM HOSPITAL STOCK AND NOT PROVIDED BY BOSTON SCIENTIFIC.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT OF THIS TACTRA MALLEABLE PENILE PROSTHESIS, A CROSS-OVER OCCURRED DURING DILATION OF THE CORPORA RESULTING IN A PERFORATION ON THE RIGHT SIDE. THE RIGHT CYLINDER WAS REMOVED WHILE THE LEFT CYLINDER REMAINED IMPLANTED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE CROSSOVER AND PERFORATION WERE IDENTIFIED VISUALLY; IT WAS NOTED TO BE VERY APPARENT AS THE PENIS WAS VERY CROOKED. IT WAS FURTHER REPORTED THE PERFORATION OCCURRED DISTALLY AFTER WHICH THE PHYSICIAN ELECTED TO KEEP A CATHETER PLACED IN THE PATIENT AS WELL AS THE LEFT CYLINDER IN ORDER TO PRESERVE SPACE. THE PATIENT REMAINS UNDER THE PHYSICIAN'S CARE. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1211666 TACTRA MALLEABLE PENILE PROTHESIS PROSTHESIS PENILE FAE BOSTON SCIENTIFIC CORPORATION 720081-01 0024301849 08714729979357

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R