BEUDAMED
    FDA Adverse Event Injury Summary report: N

    0.035" SUREGLIDE, BOX OF 5

    MDR report key: 12014265 · Received June 16, 2021

    Report

    Report Number
    3003790304-2021-00107
    Event Type
    Injury
    Date Received
    June 16, 2021
    Date of Event
    April 20, 2021
    Report Date
    July 30, 2021
    Manufacturer
    LAKE REGION MANUFACTURING
    Product Code
    EYA
    UDI-DI
    00821925005730
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT WAS SUBMITTED TO PROVIDE ADDITIONAL INFORMATION FROM THE LEGAL MANUFACTURER. THE LEGAL MANUFACTURER PERFORMED THE DEVICE HISTORY RECORDS FOR THIS DEVICE AND ALL RECORDS INDICATED THAT THE PRODUCT WAS MANUFACTURED ACCORDING TO ALL APPLICABLE PROCEDURES AND MET FINAL PRODUCT RELEASE CRITERIA. NO ABNORMALITIES WERE FOUND. THE INVESTIGATION WAS COMPLETED BY THE LEGAL MANUFACTURER AND DETERMINED THAT THERE IS NO MANUFACTURING, MATERIAL OR PROCESSING RELATED CAUSE FOR THIS FAILURE MODE. A PHYSICAL EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE CUSTOMER DID NOT RETURN THE DEVICE FOR EVALUATION; THEREFORE THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, BASED ON THE INVESTIGATION, THE POTENTIAL CAUSES COULD BE ATTRIBUTED TO JOINT STRENGTH DESIGN SPECIFICATION AND OR EXCESSIVE FORCE APPLIED TO DEVICE. AS STATED ON THE IFU (INSTRUCTION FOR USE) AND AS A PREVENTIVE MEASURE, THE IFU PROVIDES THE FOLLOWING WARNINGS AND CAUTIONS: DO NOT APPLY EXCESSIVE FORCE TO ADVANCE OR WITHDRAW THE GUIDEWIRE. DOING SO MAY RESULT IN COMPLICATIONS. IF RESISTANCE IS ENCOUNTERED, DETERMINE THE CAUSE AND TAKE REMEDIAL ACTION BEFORE CONTINUING. ALSO, WHEN USING A MOVEABLE CORE GUIDEWIRE, DO NOT ATTEMPT TO ADVANCE, STIFFEN OR STRAIGHTEN THE TIP OF THE GUIDEWIRE AGAINST RESISTANCE. THE LEGAL MANUFACTURER WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE DEFINITIVE CAUSE OF THE USER'S EXPERIENCE CANNOT BE DETERMINED AT THIS TIME. THE INVESTIGATION IS ONGOING. THIS REPORT WILL BE UPDATED UPON COMPLETION OF THE INVESTIGATION OR UPON RECEIPT OF ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT IS REPORTED A PATIENT HAD A LEFT URETEROSCOPY WITH STENT FOR THE INDICATION OF LEFT URETERAL STONE (B)(6) 2020 USING A SURE GLIDE GUIDEWIRE AND AN HOLMIUM LASER (THE LASER SETTINGS WERE: 800 MJ AND 8 HZ. JOULES: 263.20, PULSES: 329, DURATION: 41 SECONDS). AFTER THE PROCEDURE, THE PATIENT EXPERIENCED URINARY URGENCY, FREQUENCY, AND URETHRAL PAIN. AN UNSPECIFIED TIME LATER, THE PATIENT HAD AN ULTRASOUND AND IT WAS FOUND THAT THE PATIENT HAD RETAINED A PORTION OF THE WIRE. THE PATIENT HAD ANOTHER URETEROSCOPY PROCEDURE (B)(6) 2021 TO TRY TO RETRIEVE THE BROKEN GUIDEWIRE WITH NO SUCCESS. THE PATIENT WAS THEN BOOKED FOR A LOWER URETERAL POLE STENT, UPPER POLE URETER URETEROSCOPY, REMOVAL OF FOREIGN BODY IN THE DISTAL URETER OF THE UPPER POLE URETER, URETERAL STENT IN UPPER POLE URETER AND REMOVAL OF STENT IN LOWER POLE AT THE LOCAL HOSPITAL TO HAVE THE DEVICE FRAGMENT REMOVED (B)(6) 2021 WHICH WAS SUCCESSFUL. THE PATIENT HAD A STENT PLACED AND CAME BACK SEVERAL WEEKS LATER TO HAVE THE STENT REMOVED AND IS NOW DOING FINE. NO FURTHER PROBLEMS. THE DEVICE FRAGMENT THAT WAS REMOVED FROM THE PATIENT WAS SENT TO PATHOLOGY. IT MEASURED 3.6CM X 0.1CM AND CAME BACK AS HYDROPHILIC NITINOL CORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    906006 0.035" SUREGLIDE, BOX OF 5 STYLET, URETERAL EYA LAKE REGION MANUFACTURING 35BX 5968188 00821925005730

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention HOLMIUM LASER| HOLMIUM LASER