BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UPHOLD VAGINAL SUPPORT SYSTEM

    MDR report key: 3881731 · Received June 18, 2014

    Report

    Report Number
    3005099803-2014-02315
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 29, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    OTP
    PMA / PMN Number
    K081048
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED UPHOLD VAGINAL SUPPORT SYSTEM DEVICE REVEALED THAT THE SUTURE ON THE BLUE DILATOR IS BROKEN AND FRAYED. 5.0 CM OF SUTURE IS STILL ATTACHED TO THE BLUE DILATOR, THE DART IS MISSING, AND NOT RETURNED. THERE IS NO DAMAGE TO THE CAPIO SUTURING 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.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT OF NEEDLE DETACHMENT. 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 MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPHOLD VAGINAL SUPPORT SYSTEM WAS USED DURING A CORRECTION OF APICAL ANTERIOR PROLAPSE STAGE III PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, THE SUTURE BROKE WHILE THE PHYSICIAN WAS PULLING THE CAPIO DEVICE THROUGH THE SACROSPINOUS LIGAMENT. NOTHING WAS LEFT BEHIND INSIDE THE PATIENT. THE PHYSICIAN FOUND THE BROKEN SUTURE TIED AT THE END OF THE CAPIO. THE PROCEDURE WAS COMPLETED WITH ANOTHER UPHOLD VAGINAL SUPPORT SYSTEM. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPHOLD VAGINAL SUPPORT SYSTEM WAS USED DURING A CORRECTION OF APICAL ANTERIOR PROLAPSE STAGE III PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, THE SUTURE BROKE WHILE THE PHYSICIAN WAS PULLING THE CAPIO DEVICE THROUGH THE SACROSPINOUS LIGAMENT. NOTHING WAS LEFT BEHIND INSIDE THE PATIENT. THE PHYSICIAN FOUND THE BROKEN SUTURE TIED AT THE END OF THE CAPIO. THE PROCEDURE WAS COMPLETED WITH ANOTHER UPHOLD VAGINAL SUPPORT SYSTEM. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357659 UPHOLD VAGINAL SUPPORT SYSTEM MESH, SURGICAL, SYNTHETIC OTP BOSTON SCIENTIFIC - MARLBOROUGH M0068317080 ML00001915

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR