BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UPHOLD VAGINAL SUPPORT SYSTEM

    MDR report key: 4939446 · Received July 24, 2015

    Report

    Report Number
    3005099803-2015-02002
    Event Type
    Malfunction
    Date Received
    July 24, 2015
    Date of Event
    June 30, 2015
    Report Date
    June 29, 2015
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    OTP
    PMA / PMN Number
    K081048
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. PROBLEM OF LEAD SUTURE BROKE. (B)(6).

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED UPHOLD VAGINAL SUPPORT SYSTEM REVEALED THAT THE SUTURE IS BROKEN ON THE BLUE DILATOR. ANALYSIS REVEALED THAT THE DART WAS RETURNED INSIDE THE CAPIO SUTURE CAPTURING DEVICE. THE DART HAS A SMALL AMOUNT OF SUTURE ATTACHED TO IT. ALSO, THERE IS NO DAMAGE TO THE CAPIO SUTURE CAPTURING DEVICE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. THE INVESTIGATION CONCLUDED THAT THIS COMPLAINT IS ASSOCIATED WITH A PRODUCT THAT MEETS THE DESIGN AND MANUFACTURE SPECIFICATIONS BUT DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, PERFORMANCE OF THE DEVICE WAS LIMITED. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPHOLD VAGINAL SUPPORT SYSTEM WAS DURING A CYCTOCELE PROLAPSE STAGE III REPAIR PROCEDURE DONE ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SUTURE BROKE. THE NEEDLE WAS FOUND LODGED IN THE CAPIO CAGE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPHOLD VAGINAL SUPPORT SYSTEM WAS DURING A CYSTOCELE PROLAPSE STAGE III REPAIR PROCEDURE DONE ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SUTURE BROKE. THE NEEDLE WAS FOUND LODGED IN THE CAPIO CAGE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481848 UPHOLD VAGINAL SUPPORT SYSTEM MESH, SURGICAL, SYNTHETIC OTP BOSTON SCIENTIFIC - MARLBOROUGH M0068317080 ML00002101

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR