BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VORTEK PERCUTANEOUS NEPHROSTOMY KIT WITH J CATHETER

    MDR report key: 21049332 · Received December 31, 2024

    Report

    Report Number
    9610711-2024-00355
    Event Type
    Injury
    Date Received
    December 31, 2024
    Date of Event
    December 3, 2024
    Report Date
    June 26, 2025
    Manufacturer
    COLOPLAST A/S
    Product Code
    LJE
    UDI-DI
    03600040257951
    PMA / PMN Number
    K211911
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. WITHOUT THE BENEFIT OF ANALYZING THE DEVICE, COLOPLAST CANNOT COMMENT ON THE CONDITION OF THE DEVICE. SHOULD ADDITIONAL INFORMATION PROMPT US TO ALTER OR SUPPLEMENT ANY INFORMATION OR CONCLUSIONS CONTAINED IN THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE COMPLAINT DESCRIPTION, THE LOT NUMBER IS AVAILABLE BUT NOT THE SAMPLE. THE REVIEW OF THE COMPLAINT HISTORY DATABASE, REVEALED NO TRENDS FOR THE LOT NUMBER 8351861. THE PRODUCT REFERENCE IS A KIT. IT WAS COMPOSED WITH FOLLOWING COMPONENTS: GUIDEWIRE: ITEM NUMBER SQ224690 LOT NUMBER 8181262. CHIBA NEEDLE 22G: ITEM NUMBER SS720190 LOT NUMBER 8058806, 8071819. CHIBA NEEDLE 18G: ITEM NUMBER SS720390 LOT NUMBER 8181265. DILATOR CH06/08: ITEM NUMBER YD251290 LOT NUMBER 8115112, 8131069. J CATHETER: ITEM NUMBER YJ160890 LOT NUMBER 8214999 & 8214998. THIS ISSUE DESCRIBED CONCERNED THE J CATHETER. THE QUALITY DATABASE WAS CHECKED AND REVEALED ONE CORRECTIVE AND PREVENTIVE ACTION OPENED IN MARCH FOR "MANDREL BLOCKED IN YJ16XX". THE ROOT CAUSE ANALYSIS IS ONGOING AT THIS TIME AND ACTIONS WILL FOLLOW THE RESULTS OF THIS ANALYSIS. A SIMILAR CASE STUDY WAS PERFORMED BASED ON SAME PRODUCT AND SAME DEFECT (FUNCTIONALITY MANDRIN STUCK) FROM (B)(6) 2020 TO (B)(6) 2024: 21 SIMILAR CASES WERE FOUND. A RISK MANAGEMENT FILE EVALUATION WAS PERFORMED AND IT WAS CONCLUDED 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.

    Additional Manufacturer Narrative · 0

    B1, H1: UPGRADED FROM MALFUNCTION TO SERIOUS INJURY AS THE PROLONGED PROCEDURE WAS CONSIDERED CLINICALLY SIGNIFICANT.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION, THE CATHETER GUIDE BROKE DURING REPLACEMENT. THIS EVENT LED TO COMPLICATIONS IN THE SURGICAL PROCEDURE, WITH A HIGH RISK OF FAILURE, LENGTHENING OF THE PROCEDURE AND THE USE OF A NEW DEVICE.

    Description of Event or Problem · 0

    ACCORDING TO ADDITIONAL INFORMATION RECEIVED, IT WAS JUST THE WHITE LUER THAT HAD COME OFF, IT WAS NOT THE METAL SHAFT BREAKING INTO TWO. THERE WAS SOME RESISTANCE WHEN REMOVING THE MANDREL. A NEW KIT WAS USED FOR THE CATHETER WITH THE MANDREL ONLY. THE PREVIOUS GUIDEWIRE WAS IN PLACE AND THE PATH DILATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1089261 VORTEK PERCUTANEOUS NEPHROSTOMY KIT WITH J CATHETER UROLOGICAL SURGICAL PROCEDURE KIT, NON-MEDICATED, SINGLE USE LJE COLOPLAST A/S 8351861_RJA2101002 03600040257951

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other