BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UPHOLD¿ LITE

    MDR report key: 7535089 · Received May 22, 2018

    Report

    Report Number
    3005099803-2018-01514
    Event Type
    Injury
    Date Received
    May 22, 2018
    Date of Event
    April 25, 2018
    Report Date
    April 25, 2018
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    OTP
    UDI-DI
    08714729839200
    PMA / PMN Number
    K122459
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    A VISUAL EXAMINATION OF THE RETURNED UPHOLD¿ LITE WITH CAPIO SLIM REVEALED THAT ONLY TWO DILATORS AND PART OF A SUTURE WERE RETURNED. THE SUTURE ON THE BLUE WITH WHITE STRIPE DILATOR WAS CUT. THE REMAINDER OF THE SUTURE WITH DART WAS NOT RETURNED. THE USER MOST LIKELY CUT THE SUTURE TO FACILITATE REMOVAL. THE SUTURE ON THE BLUE DILATOR WAS BROKEN. THE REMAINDER OF THE SUTURE WITH DART WAS NOT RETURNED. THE CAPIO SLIM SUTURE CAPTURING DEVICE 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 INVESTIGATION CONCLUDED THAT THIS COMPLAINT IS ASSOCIATED WITH A PRODUCT THAT MEETS THE DESIGN AND MANUFACTURE SPECIFICATIONS BUT DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, PERFORMANCE OF THE DEVICE WAS LIMITED. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS OPERATIONAL CONTEXT. A LABELING REVIEW WAS PERFORMED AND, FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPHOLD¿ LITE WITH CAPIO SLIM WAS IMPLANTED DURING AN ANTERIOR CYSTOCELE REPAIR WITH CYSTOSCOPY PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THEY CUT THE SUTURE, THE SLEEVE WON¿T COME OFF. THE PHYSICIAN PROCEEDED WITH THE PROCEDURE AND WHILE IMPLANTING THE DEVICE, A PIECE OF SUTURE DETACHED AND WAS INSIDE THE PATIENT. REPORTEDLY, THEY FOUND THE DETACHED SUTURE AND REMOVED IT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

    Additional Manufacturer Narrative · 1

    (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¿ LITE WITH CAPIO SLIM WAS IMPLANTED DURING AN ANTERIOR CYSTOCELE REPAIR WITH CYSTOSCOPY PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THEY CUT THE SUTURE, THE SLEEVE WON¿T COME OFF. THE PHYSICIAN PROCEEDED WITH THE PROCEDURE AND WHILE IMPLANTING THE DEVICE, A PIECE OF SUTURE DETACHED AND WAS INSIDE THE PATIENT. REPORTEDLY, THEY FOUND THE DETACHED SUTURE AND REMOVED IT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374793 UPHOLD¿ LITE MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN OTP BOSTON SCIENTIFIC - SPENCER M0068318170 21402115 08714729839200

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention