BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UPHOLD VAGINAL SUPPORT SYSTEM

    MDR report key: 2221021 · Received August 23, 2011

    Report

    Report Number
    3005099803-2011-02702
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    June 27, 2011
    Report Date
    June 28, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K081048
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE CAPIO DEVICE WAS NOT RECEIVED FOR ANALYSIS. VISUAL ANALYSIS OF THE RETURNED MESH ASSEMBLY REVEALED THAT THE LEAD SUTURE WAS BROKEN OFF THE BLUE AND WHITE DILATOR, WHICH WAS RECEIVED SEPARATELY. IN ADDITION, TOOL MARKS WERE OBSERVED ON THE DISTAL END OF THE BLUE AND WHITE DILATOR. 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

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING A SACROSPINOUS LIGAMENT FIXATION PROCEDURE, USING AN UPHOLD VAGINAL SUPPORT SYSTEM, THE PHYSICIAN EXPERIENCED DIFFICULTY ADVANCING THE DEVICE. AS THE PHYSICIAN WAS PULLING THE NEEDLE WITH THE CAPIO DEVICE OUTSIDE THE PATIENT, THE NEEDLE DETACHED. THE DETACHED NEEDLE REPORTEDLY DID NOT FALL INSIDE THE PATIENT, AND WAS PUT TO THE SIDE. THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER UPHOLD VAGINAL SUPPORT SYSTEM WITH NO COMPLICATIONS TO THE PATIENT, WHO IS REPORTEDLY FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UPHOLD VAGINAL SUPPORT SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068317080 ML00000106

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR