BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARTRACT

    MDR report key: 23811813 · Received December 15, 2025

    Report

    Report Number
    3014650073-2025-00001
    Event Type
    Malfunction
    Date Received
    December 15, 2025
    Date of Event
    December 5, 2023
    Report Date
    November 11, 2025
    Manufacturer
    SILQ TECHNOLOGIES CORPORATION
    Product Code
    EZL
    UDI-DI
    00850041415154
    PMA / PMN Number
    K192034
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    IMMEDIATELY UPON NOTIFICATION OF THE EVENT, SILQ RECEIVED THE DEVICE IN QUESTION AND VERIFIED THAT THE CATHETER BALLOON DID RUPTURE. CATHETER WAS SUCCESSFULLY REPLACED WITH A NEW DEVICE WITHOUT ISSUE. THE ANALYSIS OF THE RETURNED DEVICE WAS UNABLE TO ESTABLISH IF THE EVENT WAS CAUSED BY AN ISSUE WITH THE DEVICE OR WAS CAUSED BY THE SPECIFIC CONDITIONS OF THE PATIENT'S BLADDER, SUCH AS PRESENCE OF BLADDER STONES. SILQ HAS CONTINUED TO MONITOR ALL PRODUCT COMPLAINTS FOR RECURRENCE OF THIS ISSUE AND IS NOT AWARE OF ANY SUBSEQUENT INSTANCES.

    Description of Event or Problem · 0

    A PATIENT PARTICIPATING IN A CLINICAL STUDY (B)(6) WAS PROVIDED A 2-WAY 100% SILICONE, 16FR X 10ML, CLEARTRACT SPT CATHETER (PRIMARY DI: (B)(4)). THE CATHETER WAS INSERTED WITH NO APPARENT ISSUES BY A NURSE AT (B)(6) ON (B)(6) 2023. ON (B)(6) 2023, THE PATIENT RETURNED COMPLAINING OF PAIN AND DISCOMFORT. THE ATTENDING NURSE TRIED TO DEFLATE THE BALLOON TO CHECK THE POSITIONING OF THE CATHETER AND THE BALLOON DID NOT HAVE ANY WATER IN IT. THE NURSE TRIED TO ADD WATER TO THE BALLOON, HOWEVER, ALL OF THE WATER FROM THE BALLOON RAN IMMEDIATELY OUT OF THE URETHRA ALONG THE CATHETER. THE NURSE THEN REMOVED THE CATHETER AND REPLACED WITH A NON-STUDY CATHETER. UPON REMOVAL OF THE SILQ CATHETER, THE NURSE NOTED THAT THE BALLOON WAS RUPTURED. (B)(6), (B)(6) COORDINATOR, REPORTED THE EVENT TO SILQ TECHNOLOGIES. SILQ TECHNOLOGIES MADE CONTACT WITH THE NURSE AND PHYSICIAN WHO INDICATED THAT THERE WAS NO INJURY TO THE PATIENT AND NO PAIN ASSOCIATED DIRECTLY WITH THE CATHETER. A SILQ EMPLOYEE VISITED THE FACILITY ON (B)(6) 2023 TO RETRIEVE THE CATHETER. FURTHER ANALYSIS CONFIRMED THE CATHETER BALLOON HAD RUPTURED, ALTHOUGH A ROOT CAUSE OF THE RUPTURE COULD NOT BE ESTABLISHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324126 CLEARTRACT 2-WAY 100% SILICONE, 16FR X 10ML, CLEARTRACT SPT CATHETER EZL SILQ TECHNOLOGIES CORPORATION 211610SPT SLQ1610-012022 00850041415154

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Unknown Required Intervention