BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLYX SIS SYSTEM

    MDR report key: 10615223 · Received October 1, 2020

    Report

    Report Number
    3005099803-2020-04174
    Event Type
    Malfunction
    Date Received
    October 1, 2020
    Date of Event
    August 6, 2020
    Report Date
    October 29, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    PAH
    PMA / PMN Number
    K081275
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCKS D4, H4: THE REPORTED LOT NUMBER 2900492 DOES NOT PROVIDE A MATCH IN THE SYSTEM SEARCH; THEREFORE, THE DEVICE MANUFACTURE AND EXPIRATION DATES CANNOT BE DETERMINED. HOWEVER, THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT EXPIRED. BLOCK H6: DEVICE CODE 1484 CAPTURES THE REPORTABLE EVENT OF UNINTENDED RELEASE OF MESH CARRIER FROM SHAFT ASSEMBLY. CONCLUSION CODE 4316 IS BEING USED IN LIEU OF AN ADEQUATE CONCLUSION CODE FOR DEVICE NOT RETURNED. BLOCK H10: THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 0

    NOTE: THIS MANUFACTURER REPORT PERTAINS TO THE FIRST OF TWO DEVICES USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO SOLYX DEVICES WERE USED DURING A SOLYX PLACEMENT FOR SUI PROCEDURE PERFORMED ON (B)(6) 2020 TO TREAT STRESS URINARY INCONTINENCE. ACCORDING TO THE COMPLAINANT, DURING THE INITIAL PLACEMENT ON (B)(6) 2020, THE MESH CARRIER DETACHED FROM THE SHAFT ASSEMBLY BEFORE THE PHYSICIAN COULD MAKE FINAL TENSIONING ADJUSTMENTS, AND HAD TO FORCEFULLY REMOVE THE SLING WHICH CAUSED TISSUE DAMAGE TO THE PATIENT. THE PHYSICIAN THEN OPENED A SECOND SOLYX DEVICE, BUT THE SAME ISSUE OCCURRED. HE THEN DECIDED TO NOT COMPLETE THE PROCEDURE AND LEAVE THE SLING TENSIONED A BIT TIGHTER THAN HE WANTED TO DECREASE TISSUE TRAUMA OF REMOVING AND REPLACING WITH ANOTHER SLING. THE PROCEDURE WAS COMPLETED IN A REVISION SURGERY ON (B)(6) 2020 WITH ANOTHER SOLYX DEVICE. ---ADDITIONAL INFORMATION RECEIVED ON OCTOBER 6, 2020--- THE REASON FOR THE REVISION SUGERY ON (B)(6) 2020 WAS NOT JUST TO REPLACE THE SLING BUT DUE TO THE PATIENT'S ADVERSE EVENT OF RETENTION AFTER THE SECOND SLING WAS LEFT IN PLACE.

    Additional Manufacturer Narrative · 1

    THE REPORTED LOT NUMBER 2900492 DOES NOT PROVIDE A MATCH IN THE SYSTEM SEARCH; THEREFORE, THE DEVICE MANUFACTURE AND EXPIRATION DATES CANNOT BE DETERMINED. HOWEVER, THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT EXPIRED. (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    THIS MANUFACTURER REPORT PERTAINS TO THE FIRST OF TWO DEVICES USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO SOLYX DEVICES WERE USED DURING A SOLYX PLACEMENT FOR SUI PROCEDURE PERFORMED ON (B)(6) 2020 TO TREAT STRESS URINARY INCONTINENCE. ACCORDING TO THE COMPLAINANT, DURING THE INITIAL PLACEMENT ON (B)(6) 2020, THE MESH CARRIER DETACHED FROM THE SHAFT ASSEMBLY BEFORE THE PHYSICIAN COULD MAKE FINAL TENSIONING ADJUSTMENTS, AND HAD TO FORCEFULLY REMOVE THE SLING WHICH CAUSED TISSUE DAMAGE TO THE PATIENT. THE PHYSICIAN THEN OPENED A SECOND SOLYX DEVICE, BUT THE SAME ISSUE OCCURRED. HE THEN DECIDED TO NOT COMPLETE THE PROCEDURE AND LEAVE THE SLING TENSIONED A BIT TIGHTER THAN HE WANTED TO DECREASE TISSUE TRAUMA OF REMOVING AND REPLACING WITH ANOTHER SLING. THE PROCEDURE WAS COMPLETED IN A REVISION SURGERY ON (B)(6) 2020 WITH ANOTHER SOLYX DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1082358 SOLYX SIS SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA PAH BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention