BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERSA SOFT URETERAL STENT SET

    MDR report key: 6799880 · Received August 17, 2017

    Report

    Report Number
    1820334-2017-02528
    Event Type
    Injury
    Date Received
    August 17, 2017
    Report Date
    December 12, 2017
    Manufacturer
    COOK INC
    Product Code
    FAD
    UDI-DI
    10827002233741
    PMA / PMN Number
    K151051
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION ¿ EVALUATION: THE INVESTIGATION INCLUDED A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), SPECIFICATIONS, AND A VISUAL INSPECTION OF THE RETURNED DEVICE. ONE UNIVERSA SOFT URETERAL STENT WAS RECEIVED IN AN OPEN PACKAGE, LABEL LOT NUMBER 7968937. ONLY A 24CM STENT WAS RETURNED. THE MONOFILAMENT TETHER HAS BEEN REMOVED FROM THE STENT. TETHER WAS SEVERED 3CM FROM THE KNOT. THE TETHER MEASURED 54CM WITH 2CM STRETCHED TO THE POINT OF SEPARATION. THIS STENT FEATURES A MONOFILAMENT TETHER DESIGNED FOR REPOSITIONING AND EASE OF REMOVAL. THE TENSILE STRENGTH OF MONOFILAMENT IS SUFFICIENT FOR REMOVAL. BASED ON THE INVESTIGATION EVALUATION, THERE IS NO INDICATION THAT A DESIGN OR PROCESS RELATED FAILURE MODE CONTRIBUTED TO THIS EVENT. A REVIEW OF PRODUCTION AND QUALITY DOCUMENTATION DID NOT IDENTIFY ANY SPECIFIC ISSUES WITH CURRENT MANUFACTURING OR QUALITY CONTROLS THAT MAY HAVE CONTRIBUTED TO THIS INCIDENT. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED THERE WERE NO NON-CONFORMANCES IDENTIFIED DURING THE MANUFACTURING PROCESS. A REVIEW OF COMPLAINT HISTORY FOR THIS PRODUCT/LOT NUMBER COMBINATION REVEALED THIS IS THE ONLY COMPLAINT THAT HAS BEEN RECEIVED FOR THIS DEVICE LOT NUMBER. BASED ON THE EVIDENCE PRESENTED BY THE SAMPLE AND THE PHYSICAL ANALYSIS, THE TETHER BEING STRETCHED AND PULLED TO SEPARATION INDICATES THIS IS THE RESULT OF PROCEDURAL HANDLING OF THE PRODUCT. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. COOK MEDICAL HAS NOTIFIED THE APPROPRIATE PERSONNEL AND WILL CONTINUE TO MONITOR THIS DEVICE VIA THE COMPLAINTS DATABASE FOR SIMILAR COMPLAINTS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE STRING SNAPPED DURING IMPLANTATION OF THE UNIVERSA SOFT URETERAL STENT SET. THE PHYSICIAN WAS ABLE TO REMOVE THE STENT INTACT AND REPLACED IT. NO SECTION OF THE DEVICE REMAINS INSIDE THE PATIENT'S BODY. NO ADDITIONAL PROCEDURES WERE REQUIRED. AS REPORTED, THERE WERE NO ADVERSE EFFECTS TO THE PATIENT DUE TO THIS OCCURRENCE. ADDITIONAL PATIENT, DEVICE AND EVENT INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580277 UNIVERSA SOFT URETERAL STENT SET FAD STENT, URETERAL FAD COOK INC G23374 10827002233741

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention