BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UPHOLD VAGINAL SUPPORT SYSTEM

    MDR report key: 1886425 · Received October 29, 2010

    Report

    Report Number
    3005099803-2010-04634
    Event Type
    Malfunction
    Date Received
    October 29, 2010
    Date of Event
    October 6, 2010
    Report Date
    October 6, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K081048
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED CAPIO SUTURING DEVICE CONFIRMED THAT THE GRAY HANDLE BECAME LOOSE FROM THE SHAFT. THE GREY HANDLE HAD MIGRATED TOWARD THE PROXIMAL END OF THE DEVICE AND WAS FOUND RESTING ON THE PLUNGER. THE CAPIO SUTURING DEVICE OPERATED FREELY AND SMOOTHLY. THE MESH ASSEMBLY WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE MANUFACTURING RECORDS FOR THIS LOT SHOWS NO EVIDENCE OF A MANUFACTURING-RELATED POTENTIAL CAUSE FOR THIS EVENT. THE MOST PROBABLE ROOT CAUSE FOR THIS EVENT IS OPERATIONAL CONTEXT.

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE PATIENT'S EXACT WEIGHT IS UNKNOWN, SHE IS REPORTED TO WEIGH (B)(6). THE COMPLAINANT INDICATED THAT THE UPHOLD MESH WAS IMPLANTED AND WILL NOT BE RETURNED FOR EVALUATION. HOWEVER, THE CAPIO DEVICE BELONGING TO THE UPHOLD KIT HAS BEEN RECEIVED FOR ANALYSIS. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE CAPIO DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    NOTE: THIS MANUFACTURER REPORT PERTAINS TO ONE OF TWO DEVICES THAT WERE USED DURING THE SAME PROCEDURE. ASSOCIATED MANUFACTURER REPORT# 3005099803-2010-04560 CONCERNS THE OTHER DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING A CYSTOCELE REPAIR AND VAGINAL VAULT SUSPENSION PROCEDURE USING AN UPHOLD VAGINAL SUPPORT SYSTEM, THE PHYSICIAN SUCCESSFULLY PLACED THE FIRST MESH LEG ASSEMBLY INTO THE PATIENT'S RIGHT SACROSPINOUS LIGAMENT. WHILE THE FIRST THROW OF THE MESH LEG THROUGH THE LIGAMENT WAS UNSUCCESSFUL, THE PHYSICIAN WAS ABLE TO RELOAD THE CAPIO DEVICE WITH THE SUTURE BELONGING TO THE MESH LEG AND IMPLANTED THE UPHOLD MESH "SECURELY" WITHIN THE PATIENT'S RIGHT SIDE. WHEN THE PHYSICIAN ATTEMPTED TO IMPLANT THE SECOND MESH LEG ASSEMBLY INTO THE PATIENT'S LEFT SACROSPINOUS LIGAMENT, THREE FAILED ATTEMPTS WERE MADE TO THROW THE MESH LEG THROUGH THE PATIENT'S TISSUE. REPORTEDLY, SCAR TISSUE OVER THE LIGAMENT WAS INTERFERING WITH PLACEMENT ACCURACY. AT THIS TIME, THE CAPIO DEVICE WAS SUCCESSFULLY TESTED OUTSIDE THE PATIENT. UPON THE FOURTH ATTEMPT TO IMPLANT THE MESH LEG ASSEMBLY INTO THE PATIENT'S LEFT SIDE, WHEN THE PHYSICIAN PUSHED THE CAPIO DEVICE WITH "SOME FORCE," THE CAPIO HANDLE BROKE INTO "2-3" PIECES OUTSIDE THE PATIENT. THE CAPIO DEVICE WAS THEN REMOVED FROM THE PATIENT WITHOUT DIFFICULTY. THE PHYSICIAN THEN LOADED THE SUTURE BELONGING TO THE SECOND MESH LEG ASSEMBLY ONTO A STAND-ALONE CAPIO DEVICE (MANUFACTURED BY BOSTON SCIENTIFIC CORPORATION). HOWEVER, WHEN THE PHYSICIAN ATTEMPTED TO THROW THE SUTURE THROUGH THE PATIENT'S SACROSPINOUS LIGAMENT, THE NEEDLE ATTACHED TO THE SUTURE DETACHED AND WAS CAPTURED INSIDE THE CAPIO CAGE. THE NEEDLE DID NOT FALL INSIDE THE PATIENT. THE STAND-ALONE CAPIO DEVICE WAS THEN LOADED WITH A STAND-ALONE CAPIO SUTURE (MANUFACTURED BY TELEFLEX MEDICAL INC, DISTRIBUTED BY (B)(4)) AND FOUR ATTEMPTS WERE MADE TO SECURE THE UPHOLD DEVICE WITH THIS SUTURE. HOWEVER, THE CAPIO CAGE, WHICH WOULD SUCCESSFULLY CAPTURE THE NEEDLE, WOULD LET GO OF THE NEEDLE AS THE CAPIO DEVICE WAS PULLED OUT OF THE PATIENT. THE PHYSICIAN ALSO REPORTED THAT THE DISSECTION PORTION OF THE PROCEDURE WAS VERY CHALLENGING DUE TO COPIOUS AMOUNTS OF SCAR TISSUE FROM A PREVIOUS ANTERIOR REPAIR (PLICATION TECHNIQUE) THAT WAS PERFORMED "SEVERAL YEARS EARLIER." THE PROCEDURE, WHICH LASTED APPROXIMATELY "ONE HOUR LONGER THAN NORMAL", WAS COMPLETED WITH THIS UPHOLD VAGINAL SUPPORT SYSTEM AND ANOTHER STAND-ALONE CAPIO DEVICE WITHOUT ANY COMPLICATIONS TO THE PATIENT, WHO IS REPORTEDLY DOING "FINE" POST-PROCEDURE. "NORMAL" BLOOD LOSS DURING THE PROCEDURE WAS REPORTED.

    Description of Event or Problem · 1

    NOTE: THIS MANUFACTURER REPORT PERTAINS TO ONE OF TWO DEVICES THAT WERE USED DURING THE SAME PROCEDURE. ASSOCIATED MANUFACTURER REPORT# 3005099803-2010-04560 CONCERNS THE OTHER DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING A CYSTOCELE REPAIR AND VAGINAL VAULT SUSPENSION PROCEDURE USING AN UPHOLD VAGINAL SUPPORT SYSTEM, THE PHYSICIAN SUCCESSFULLY PLACED THE FIRST MESH LEG ASSEMBLY INTO THE PATIENT'S RIGHT SACROSPINOUS LIGAMENT. WHILE THE FIRST THROW OF THE MESH LEG THROUGH THE LIGAMENT WAS UNSUCCESSFUL, THE PHYSICIAN WAS ABLE TO RELOAD THE CAPIO DEVICE WITH THE SUTURE BELONGING TO THE MESH LEG AND IMPLANTED THE UPHOLD MESH "SECURELY" WITHIN THE PATIENT'S RIGHT SIDE. WHEN THE PHYSICIAN ATTEMPTED TO IMPLANT THE SECOND MESH LEG ASSEMBLY INTO THE PATIENT'S LEFT SACROSPINOUS LIGAMENT, THREE FAILED ATTEMPTS WERE MADE TO THROW THE MESH LEG THROUGH THE PATIENT'S TISSUE. REPORTEDLY, SCAR TISSUE OVER THE LIGAMENT WAS INTERFERING WITH PLACEMENT ACCURACY. AT THIS TIME, THE CAPIO DEVICE WAS SUCCESSFULLY TESTED OUTSIDE THE PATIENT. UPON THE FOURTH ATTEMPT TO IMPLANT THE MESH LEG ASSEMBLY INTO THE PATIENT'S LEFT SIDE, WHEN THE PHYSICIAN PUSHED THE CAPIO DEVICE WITH "SOME FORCE," THE CAPIO HANDLE BROKE INTO "2-3" PIECES OUTSIDE THE PATIENT. THE CAPIO DEVICE WAS THEN REMOVED FROM THE PATIENT WITHOUT DIFFICULTY. THE PHYSICIAN THEN LOADED THE SUTURE BELONGING TO THE SECOND MESH LEG ASSEMBLY ONTO A STAND-ALONE CAPIO DEVICE (MANUFACTURED BY BOSTON SCIENTIFIC CORPORATION). HOWEVER, WHEN THE PHYSICIAN ATTEMPTED TO THROW THE SUTURE THROUGH THE PATIENT'S SACROSPINOUS LIGAMENT, THE NEEDLE ATTACHED TO THE SUTURE DETACHED AND WAS CAPTURED INSIDE THE CAPIO CAGE. THE NEEDLE DID NOT FALL INSIDE THE PATIENT. THE STAND-ALONE CAPIO DEVICE WAS THEN LOADED WITH A STAND-ALONE CAPIO SUTURE (MANUFACTURED BY TELEFAX MEDICAL INC, DISTRIBUTED BY BOSTON SCIENTIFIC CORPORATION) AND FOUR ATTEMPTS WERE MADE TO SECURE THE UPHOLD DEVICE WITH THIS SUTURE. HOWEVER, THE CAPIO CAGE, WHICH WOULD SUCCESSFULLY CAPTURE THE NEEDLE, WOULD LET GO OF THE NEEDLE AS THE CAPIO DEVICE WAS PULLED OUT OF THE PATIENT. THE PHYSICIAN ALSO REPORTED THAT THE DISSECTION PORTION OF THE PROCEDURE WAS VERY CHALLENGING DUE TO COPIOUS AMOUNTS OF SCAR TISSUE FROM A PREVIOUS ANTERIOR REPAIR (PLICATION TECHNIQUE) THAT WAS PERFORMED "SEVERAL YEARS EARLIER." THE PROCEDURE, WHICH LASTED APPROXIMATELY "ONE HOUR LONGER THAN NORMAL", WAS COMPLETED WITH THIS UPHOLD VAGINAL SUPPORT SYSTEM AND ANOTHER STAND-ALONE CAPIO DEVICE WITHOUT ANY COMPLICATIONS TO THE PATIENT, WHO IS REPORTEDLY DOING "FINE" POST-PROCEDURE. "NORMAL" BLOOD LOSS DURING THE PROCEDURE WAS REPORTED.

    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 59 YR CAPIO SUTURE (MFR: TELEFLEX MEDICAL INC)| CAPIO DEVICE (MFR: BOSTON SCIENTIFIC CORP)