BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UPHOLD LITE

    MDR report key: 8617462 · Received May 16, 2019

    Report

    Report Number
    3005099803-2019-02398
    Event Type
    Injury
    Date Received
    May 16, 2019
    Date of Event
    March 6, 2019
    Report Date
    September 10, 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
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE CODE 2907 CAPTURES THE REPORTABLE EVENT OF DART DETACHMENT. OTHER: ANSM INCIDENT REPORT REFERENCE NO (B)(4); SUBMITTED TO ANSM (AGENCE NATIONALE DE SECURITE DU MEDICAMENT ET DES PRODUITS DE SANTE) BY THE HEALTHCARE FACILITY. INVESTIGATION OF THE RETURNED CAPIO SLIM DEVICE AND MESH ASSEMBLY WAS PERFORMED. THE CAPIO SLIM DEVICE WAS ABLE TO BE EXTENDED AND RETRACTED INTO THE CAGE. THE SUTURE WAS BROKEN ON THE BLUE/WHITE DILATOR. IT APPEARED TO BE BROKEN NEAR WHERE THE CAPIO SLIM CARRIER INTERACTS WITH THE DART AND SUTURE. THE DART WAS NOT RETURNED. FURTHERMORE, THERE WAS DAMAGE TO THE MESH ASSEMBLY. THERE WAS TEARING OF THE MESH AND THE LEADER LOOPS AND PROTECTIVE SLEEVES ON BOTH BLUE WHITE DILATOR AND BLUE DILATOR APPEARED TO BE CUT. BASED ON THE EVENT, THE ISSUE OF THE DART DETACHMENT OCCURRED WHILE IMPLANTING THE SECOND SIDE OF THE MESH, AND THE DEVICE WAS REMOVED SO A SECOND DEVICE COULD BE USED. IT IS LIKELY THAT THE DAMAGE ON THE MESH ASSEMBLY WAS CAUSED DURING EXPLANTING OF THE DEVICE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) INDICATED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. A LABELING REVIEW WAS PERFORMED AND, FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL. HOWEVER, BASED ON ALL GATHERED INFORMATION, THE INVESTIGATION CONCLUDED THAT THE MOST PROBABLE CAUSE FOR THE EVENT OF DART DETACHMENT/SUTURE BROKEN IS DESIGN INADEQUATE FOR PURPOSE, WHICH INDICATES THAT PROBLEMS WERE TRACED TO DESIGN/DESIGN FEATURES OF THE DEVICE THAT DO NOT SUPPORT OR DO INTERFERE WITH THE INTENDED PURPOSE OF THE DEVICE. AN INVESTIGATION WAS OPENED TO ADDRESS THE FAILURE OF DART DETACHMENT/SUTURE BROKEN. THAT INVESTIGATION FOUND THAT THE DESIGN OF THE CARRIER ALLOWS THE FIBER PORTION OF THE SUTURE TO INTERACT WITH THE SHARP EDGE OF THE CARRIER, RESULTING IN SUTURE SEVERING. CHANGES TO THE CARRIER DESIGN AND PROCESS TO DECREASE THE EDGE SHARPNESS WERE IMPLEMENTED ON DECEMBER 13, 2018; HOWEVER, THE COMPLAINT DEVICE WAS MANUFACTURED PRIOR TO IMPLEMENTATION OF THESE CHANGES.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPHOLD LITE WITH CAPIO SLIM DEVICE WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AFTER DEPLOYMENT OF THE DEVICE ON THE SECOND SIDE OF THE PATIENT, IT WAS NOTICED THAT THE DART DETACHED FROM THE SUTURE. REPORTEDLY, A TEST WAS PERFORMED TO REVEAL THE PRESENCE OR ABSENCE OF THE DART INSIDE THE PATIENT BY INJECTING PHYSIOLOGICAL SALINE WAS BUT THE TEST WAS UNSUCCESSFUL. THE PROCEDURE WAS COMPLETED WITH ANOTHER UPHOLD LITE WITH CAPIO SLIM. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). 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 LITE WITH CAPIO SLIM DEVICE WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AFTER DEPLOYMENT OF THE DEVICE ON THE SECOND SIDE OF THE PATIENT, IT WAS NOTICED THAT THE DART DETACHED FROM THE SUTURE. REPORTEDLY, A TEST WAS PERFORMED TO REVEAL THE PRESENCE OR ABSENCE OF THE DART INSIDE THE PATIENT BY INJECTING PHYSIOLOGICAL SALINE WAS BUT THE TEST WAS UNSUCCESSFUL. THE PROCEDURE WAS COMPLETED WITH ANOTHER UPHOLD LITE WITH CAPIO SLIM. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409471 UPHOLD LITE MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN OTP BOSTON SCIENTIFIC CORPORATION M0068318170 0022874840 08714729839200

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention