BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UPHOLD VAGINAL SUPPORT SYSTEM

    MDR report key: 2030032 · Received March 25, 2011

    Report

    Report Number
    3005099803-2011-00919
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 2, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K081048
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: VISUAL ANALYSIS OF THE RETURNED MESH ASSEMBLY REVEALED THAT THE NEEDLE FROM THE BLUE AND WHITE DILATOR WAS BROKEN OFF FROM THE BLUE AND WHITE DILATOR. VISUAL ANALYSIS OF THE RETURNED CAPIO DEVICE REVEALED THAT THE NEEDLE WAS RECEIVED INSIDE THE CAPIO CAGE. NO DEFECTS WERE NOTED. FUNCTIONAL TESTING OF THE RETURNED CAPIO DEVICE SHOWED THAT IT OPERATED FREELY AND SMOOTHLY. A REVIEW OF THE MANUFACTURING RECORDS FOR THIS LOT SHOWED NO EVIDENCE OF A MANUFACTURING-RELATED POTENTIAL CAUSE FOR THIS EVENT. ADDITIONAL INFORMATION 'TYPE OF REPORTABLE EVENT' WAS UPDATED FROM 'SERIOUS INJURY' TO 'MALFUNCTION', AND 'AE OR PRODUCT PROBLEM' WAS UPDATED FROM 'REPORTED ISSUE IS BOTH AN ADVERSE EVENT AND PRODUCT PROBLEM' TO 'PRODUCT PROBLEM' TO REFLECT THAT THE NEEDLE WAS NOT LEFT INSIDE THE PATIENT AS WAS INITIALLY REPORTED, BUT WAS INSTEAD RECEIVED INSIDE THE CAPIO CAGE OF THE RETURNED CAPIO DEVICE.

    Additional Manufacturer Narrative · 1

    (B)(4) - SUTURE DETACHMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING AN ANTERIOR REPAIR USING AN UPHOLD VAGINAL SUPPORT SYSTEM, AS THE PHYSICIAN FIRED THE CAPIO DEVICE TO THROW THE MESH LEG ASSEMBLY THROUGH THE PATIENT'S RIGHT LIGAMENT, THE DEVICE "DID NOT MAKE A COMPLETE CIRCLE" AND THE NEEDLE DID NOT CATCH IN THE CAPIO CAGE, BUT WAS STUCK INSIDE THE LIGAMENT. THEN, AS THE PHYSICIAN ATTEMPTED TO REMOVE THE STUCK NEEDLE FROM THE LIGAMENT, THE NEEDLE (WITH A BIT OF SUTURE AT THE END) DETACHED FROM THE MESH LEG ASSEMBLY AND REMAINED IN THE LIGAMENT. THE PHYSICIAN REPORTEDLY DID NOT ATTEMPT TO LOCATE OR REMOVE THE NEEDLE. THE PHYSICIAN COMPLETED THIS PROCEDURE WITH "ANOTHER DEVICE" (TYPE AND MANUFACTURER UNKNOWN) WITH NO FURTHER COMPLICATIONS TO THE PATIENT, WHO IS REPORTEDLY "FINE".

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING AN ANTERIOR REPAIR USING AN UPHOLD VAGINAL SUPPORT SYSTEM, AS THE PHYSICIAN FIRED THE CAPIO DEVICE TO THROW THE MESH LEG ASSEMBLY THROUGH THE PATIENT'S RIGHT LIGAMENT, THE DEVICE "DID NOT MAKE A COMPLETE CIRCLE" AND THE NEEDLE DID NOT CATCH IN THE CAPIO CAGE, BUT WAS STUCK INSIDE THE LIGAMENT. THEN, AS THE PHYSICIAN ATTEMPTED TO REMOVE THE STUCK NEEDLE FROM THE LIGAMENT, THE NEEDLE (WITH A BIT OF SUTURE AT THE END) DETACHED FROM THE MESH LEG ASSEMBLY AND REMAINED IN THE LIGAMENT. THE PHYSICIAN REPORTEDLY DID NOT ATTEMPT TO LOCATE OR REMOVE THE NEEDLE. THE PHYSICIAN COMPLETED THIS PROCEDURE WITH "ANOTHER DEVICE" (TYPE AND MANUFACTURER UNKNOWN) WITH NO FURTHER 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 1ML0031502

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other