BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UPHOLD VAGINAL SUPPORT SYSTEM

    MDR report key: 2103086 · Received May 25, 2011

    Report

    Report Number
    3005099803-2011-01787
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    May 4, 2011
    Report Date
    May 4, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K081048
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE CAPIO DEVICE WAS NOT RECEIVED FOR ANALYSIS. VISUAL ANALYSIS OF THE RETURNED MESH ASSEMBLY REVEALED THAT THE SLEEVES HAD BEEN SEPARATED FROM THE MESH BODY, AND ONE MESH ARM WAS MISSING. PEELING, TEARING, AND TOOL MARKS WERE ALSO OBSERVED ON THE BLUE DILATOR. A PORTION OF THE LEAD SUTURE WITH NEEDLE WAS MISSING FROM THE BLUE AND WHITE DILATOR, WHICH EXHIBITED TEARING, PEELING, AND TOOL MARKS, AND WAS RECEIVED IN TWO PIECES. A REVIEW OF THE MANUFACTURING RECORDS FOR THIS LOT SHOWED NO EVIDENCE OF A MANUFACTURING-RELATED POTENTIAL CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO DEVICES USED DURING THE SAME PROCEDURE. ASSOCIATED MANUFACTURER REPORT #3005099803-2011-01832 PERTAINS TO THE SECOND DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING A UTERINE PROLAPSE REPAIR PROCEDURE USING AN UPHOLD VAGINAL SUPPORT SYSTEM, THE SECOND LEG ASSEMBLY WAS PULLED THROUGH A SACROSPINOUS LIGAMENT, AT WHICH TIME IT WAS DISCOVERED THAT THERE WAS A HALF-INCH VERTICAL SPLIT IN THE DILATOR. THE PHYSICIAN REMOVED THE SUTURE NEEDLE FROM THE CAPIO CAGE, AND USED A HEMOSTAT ON THE SUTURE TO CONTINUE PULLING THE LEG ASSEMBLY. AS HE WAS DOING SO, ABOUT ONE HALF-INCH OF THE SUTURE, WITH THE NEEDLE AT THE END, DETACHED FROM THE LEG ASSEMBLY. THE SUTURE PIECE WITH THE NEEDLE DID NOT FALL LOOSE INTO THE PATIENT, AND WAS REMOVED ALONG WITH THE HEMOSTAT. THE PHYSICIAN REMOVED THIS UPHOLD DEVICE FROM THE PATIENT AND COMPLETED THE PROCEDURE WITH ANOTHER UPHOLD VAGINAL SUPPORT SYSTEM, WITH NO COMPLICATIONS TO THE PATIENT, WHO IS REPORTEDLY FINE AND IS OVER 18 YEARS OF AGE.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO DEVICES USED DURING THE SAME PROCEDURE. ASSOCIATED MANUFACTURER REPORT #3005099803-2011-01832 PERTAINS TO THE SECOND DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING A UTERINE PROLAPSE REPAIR PROCEDURE USING AN UPHOLD VAGINAL SUPPORT SYSTEM, THE SECOND LEG ASSEMBLY WAS PULLED THROUGH A SACROSPINOUS LIGAMENT, AT WHICH TIME IT WAS DISCOVERED THAT THERE WAS A HALF-INCH VERTICAL SPLIT IN THE DILATOR. THE PHYSICIAN REMOVED THE SUTURE NEEDLE FROM THE CAPIO CAGE, AND USED A HEMOSTAT ON THE SUTURE TO CONTINUE PULLING THE LEG ASSEMBLY. AS HE WAS DOING SO, ABOUT ONE HALF-INCH OF THE SUTURE, WITH THE NEEDLE AT THE END, DETACHED FROM THE LEG ASSEMBLY. THE SUTURE PIECE WITH THE NEEDLE DID NOT FALL LOOSE INTO THE PATIENT, AND WAS REMOVED ALONG WITH THE HEMOSTAT. THE PHYSICIAN REMOVED THIS UPHOLD DEVICE FROM THE PATIENT AND COMPLETED THE PROCEDURE WITH ANOTHER UPHOLD VAGINAL SUPPORT SYSTEM, WITH NO COMPLICATIONS TO THE PATIENT, WHO IS REPORTEDLY FINE AND IS OVER 18 YEARS OF AGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UPHOLD VAGINAL SUPPORT SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068317080 1ML1022205

    Patients

    Seq Age Sex Outcome Treatment
    1 UPHOLD VAGINAL SUPPORT SYSTEM