BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOLYSIL SILICONE CATHETER

    MDR report key: 21643497 · Received March 19, 2025

    Report

    Report Number
    9610711-2025-00055
    Event Type
    Injury
    Date Received
    March 19, 2025
    Date of Event
    February 1, 2025
    Report Date
    June 26, 2025
    Manufacturer
    COLOPLAST A/S
    Product Code
    EZL
    UDI-DI
    03600040126844
    PMA / PMN Number
    K233411
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION PROMPT US TO ALTER OR SUPPLEMENT ANY INFORMATION OR CONCLUSIONS CONTAINED IN THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED. B3: ESTIMATED DATE.

    Additional Manufacturer Narrative · 0

    AFTER RECEIVING THIS COMPLAINT, WE SEARCHED FOR OTHER COMPLAINTS AND WE FOUND NONE REGARDING THE LOT NUMBER 9940965 FOR THE SAME DEFECT. THIS CATHETER REFERENCE WAS MADE WITH ONE TUBE COMPONENT WHICH COMPOSED THE ¿BODY¿ OF THE CATHETER. THEN THE BALLOON IS GLUED AROUND THE TUBE. THE TIP IS NOT GLUEING, SO IT CANNOT BE UNGLUEING, THERE ARE NO STRUCTURAL WEAKNESSES LINKED TO ASSEMBLY ON THIS PART OF THE CATHETER. THIS KIND OF DEFECT MAY BE DUE TO AN EXCESS OF FORCE APPLIED ON THE MEDICAL DEVICE OR A SHARP INSTRUMENT THAT DAMAGED CATHETER. ONCE A SILICONE CATHETER IS DAMAGED, EVEN SLIGHTLY, THE MATERIAL BECOMES MORE FRAGILE AND TEARS MORE EASILY. IN THE PHOTO, THE BREAK LOOKS CLEAN AND REGULAR, WHICH MAY CORRESPOND TO A CUT PRODUCT. THE BALLOON HAS PROBABLY DEFLATED AS A RESULT. BUT WITHOUT THE SAMPLE AND THE ADDITIONAL INFORMATION REQUESTED, WE CANNOT INVESTIGATE FURTHER AND VERIFY THESE HYPOTHESIS. ACCORDING TO THE INFORMATIONS KNOWN QUALITY DATABASE WAS CHECKED AND REVEALED NO ANOMALY IN RELATION TO THE DESCRIBE DEFECT. A SIMILAR CASE STUDY WAS PERFORMED BASED ON FOLYSIL CATHETER DEFECT DISTAL TIP BROKEN, OVER LAST FOUR YEARS: 43 SIMILAR CASES WERE FOUND. THE EVALUATION HAS SHOWED THAT RISKS ARE ADEQUATELY CONTROLLED AND REDUCED AS FAR AS POSSIBLE IN THE STATE OF ART LEVEL. BASED ON THIS, WE CAN CONCLUDE THAT RESIDUAL RISKS ARE ADEQUATELY CONTROLLED AND REDUCED AS FAR AS POSSIBLE, AND THE RESIDUAL RISKS ASSOCIATED WITH THE USE OF THE PRODUCT ARE ACCEPTABLE WHEN WEIGHED AGAINST THE BENEFITS TO THE PATIENT/USER. IT IS CONCLUDED THAT THE RISKS IDENTIFIED ARE STILL ACCEPTABLE AND CONSIDERED AS SAFE.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION, WHEN FILLING THE BALLOON TO 1.5 ML, THERE WAS AN ACCIDENTAL EXIT OF THE BLADDER CATHETER AND A RUPTURE OF THE BALLOON AND TIP. THE TIP WAS MISSING AND ESTIMATED TO BE APPROXIMATELY 1 CM IN SIZE. THE PATIENT UNDERWENT TWO INTRAOPERATIVE X-RAYS AND AN EXPLORATORY CYSTOSCOPY. NO FOREIGN BODY WAS FOUND. THE EXTRA PROCEDURES AND THE GENERAL ANESTHESIA TIME ADDED LENGTH TO THE PROCEDURE.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION, WHEN FILLING THE BALLOON TO 1.5 ML, THERE WAS AN ACCIDENTAL EXIT OF THE BLADDER CATHETER AND A RUPTURE OF THE BALLOON AND TIP. THE TIP WAS MISSING AND ESTIMATED TO BE APPROXIMATELY 1 CM IN SIZE. THE PATIENT UNDERWENT TWO INTRAOPERATIVE X-RAYS AND AN EXPLORATORY CYSTOSCOPY. NO FOREIGN BODY WAS FOUND. THE EXTRA PROCEDURES AND THE GENERAL ANESTHESIA TIME ADDED LENGTH TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    900716 FOLYSIL SILICONE CATHETER INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL EZL COLOPLAST A/S 9940965_AA61061002 03600040126844

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention