BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UPHOLD LITE

    MDR report key: 8150623 · Received December 11, 2018

    Report

    Report Number
    3005099803-2018-61684
    Event Type
    Injury
    Date Received
    December 11, 2018
    Date of Event
    November 9, 2018
    Report Date
    February 13, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OTP
    UDI-DI
    08714729839200
    PMA / PMN Number
    K122459
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT WEIGHT: 65.9KG. REPORTED PHYSICIAN'S CONTACT NUMBER: +011(886)422052121#3695 (B)(4). AN EXAMINATION OF THE RETURNED CAPIO SLIM SUTURE CAPTURING DEVICE WAS PERFORMED AND NO DAMAGE WAS NOTED. A FUNCTIONAL ASSESSMENT REVEALED THAT THE CARRIER RETRACTED AND EXTENDED INTO THE CAGE WITH NO ISSUE. THE CAGE OF THE CAPIO SLIM SUTURE CAPTURING DEVICE WAS REMOVED; THERE WAS NO DETACHED DART OR SUTURE INSIDE. THE MESH ASSEMBLY WAS NOT RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. THE COMPLAINT INVESTIGATION CONCLUSION CODE SELECTED IS NO PROBLEM DETECTED, WHICH INDICATES THAT THE DEVICE COMPLAINT OR PROBLEM CANNOT BE CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPHOLD (TM) LITE W/ CAPIO SLIM WAS USED DURING ANTERIOR PROLAPSE REPAIR WITH UPHOLD LITE PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, THE FIRST OPENED DEVICE FAILED TO PENETRATE TISSUE, SO A SECOND KIT WAS OPENED BUT THE PHYSICIAN USED THE CAPIO SLIM DEVICE FROM THE FIRST KIT. REPORTEDLY, AFTER DEPLOYMENT OF THE SUTURE FROM THE SECOND KIT, THE DART DETACHED FROM THE SUTURE. THE DETACHED PIECE WAS RETRIEVED FROM THE PATIENT. HOWEVER, IT IS UNKNOWN HOW IT WAS RETRIEVED. IT WAS ALSO REPORTED THAT THE SUTURE WAS NOT TENSIONED AND WAS LEFT FREE HANGING DURING DEPLOYMENT. THE SUTURE WAS DEPLOYED SEVERAL TIMES BEFORE THE DART DETACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME UPHOLD LITE W/ CAPIO SLIM. THERE WERE NO SERIOUS INJURY OR ADVERSE PATIENT EFFECTS REPORTED. THE CONDITION OF THE PATIENT AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). MANUFACTURING SITE: ALTHOUGH THE CURRENT MANUFACTURING SITE FOR UPHOLD LITE IS BOSTON SCIENTIFIC IN SPENCER IN, THE REPORTED LOT INVOLVED IN THIS COMPLAINT WAS MANUFACTURED BY: (B)(4). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPHOLD (TM) LITE W/ CAPIO SLIM WAS USED DURING ANTERIOR PROLAPSE REPAIR WITH UPHOLD LITE PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, THE FIRST OPENED DEVICE FAILED TO PENETRATE TISSUE, SO A SECOND KIT WAS OPENED BUT THE PHYSICIAN USED THE CAPIO SLIM DEVICE FROM THE FIRST KIT. REPORTEDLY, AFTER DEPLOYMENT OF THE SUTURE FROM THE SECOND KIT, THE DART DETACHED FROM THE SUTURE. THE DETACHED PIECE WAS RETRIEVED FROM THE PATIENT. HOWEVER, IT IS UNKNOWN HOW IT WAS RETRIEVED. IT WAS ALSO REPORTED THAT THE SUTURE WAS NOT TENSIONED AND WAS LEFT FREE HANGING DURING DEPLOYMENT. THE SUTURE WAS DEPLOYED SEVERAL TIMES BEFORE THE DART DETACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME UPHOLD LITE W/ CAPIO SLIM. THERE WERE NO SERIOUS INJURY OR ADVERSE PATIENT EFFECTS REPORTED. THE CONDITION OF THE PATIENT AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    992417 UPHOLD LITE MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN OTP BOSTON SCIENTIFIC CORPORATION M0068318170 0000061420 08714729839200

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention