BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UPHOLD VAGINAL SUPPORT SYSTEM

    MDR report key: 1951115 · Received January 6, 2011

    Report

    Report Number
    3005099803-2010-05305
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 13, 2010
    Report Date
    December 13, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K081048
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE THE PATIENT'S EXACT AGE IS UNKNOWN, SHE IS REPORTEDLY OVER 18 YEARS OF AGE. DEVICE EVALUATION: PHYSICAL ANALYSIS OF THE RETURNED MESH BODY REVEALED THAT THE NEEDLE WAS MISSING FROM THE BLUE AND WHITE DILATOR, CONFIRMING THE REPORTED EVENT. A CAPIO SUTURE CAPTURING DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE MANUFACTURING RECORDS FOR THIS LOT SHOWED NO EVIDENCE OF A MANUFACTURING-RELATED POTENTIAL CAUSE FOR THIS EVENT. THE DIRECTIONS FOR USE FOR THE DEVICE INCLUDES THE FOLLOWING PRECAUTION STATEMENT: "AVOID EXCESSIVE TENSION ON THE MESH DURING HANDLING AND POSITIONING TO PREVENT DAMAGE TO THE DEVICE." THE MOST PROBABLE ROOT CAUSE FOR THIS EVENT IS OPERATIONAL CONTEXT.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON 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.(B)(4).

    Description of Event or Problem · 1

    THE NEEDLE REPORTEDLY DETACHED AS THE PHYSICIAN WAS PULLING THE SECOND MESH LEG ASSEMBLY THROUGH THE TISSUE WITH THE CAPIO SUTURE CAPTURING DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING AN ANTERIOR PELVIC FLOOR REPAIR PROCEDURE USING AN UPHOLD VAGINAL SUPPORT SYSTEM, THE PHYSICIAN THREW THE SECOND LEG OF THE MESH LEG ASSEMBLY THROUGH THE SACROSPINOUS LIGAMENT. HOWEVER, THE NEEDLE REPORTEDLY DETACHED AS THE PHYSICIAN WAS PULLING THE SECOND MESH LEG ASSEMBLY THROUGH THE TISSUE. IT WAS REPORTED THAT "ABOUT ONE HALF CENTIMETER" OF SUTURE REMAINED ATTACHED TO THE NEEDLE. THE NEEDLE WITH ATTACHED SUTURE REPORTEDLY WAS CAPTURED INSIDE THE CAPIO SUTURING DEVICE CAGE UPON DETACHMENT AND DID NOT FALL INTO THE PATIENT CAVITY. THE COMPLAINANT INDICATED THAT THE NEEDLE WAS REMOVED FROM THE CAPIO DEVICE, AND THE UPHOLD MESH ASSEMBLY WAS REMOVED FROM THE PATIENT. THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER UPHOLD VAGINAL SUPPORT SYSTEM WITH NO COMPLICATIONS TO THE PATIENT, WHO IS REPORTEDLY "FINE" POST-PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UPHOLD VAGINAL SUPPORT SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068317080 1ML0070603

    Patients

    Seq Age Sex Outcome Treatment
    1