BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCUTANEOUS NEPHROSTOMY SET WITH SIMPLE LOOP VORTEK CATHETER

    MDR report key: 20759290 · Received November 22, 2024

    Report

    Report Number
    9610711-2024-00326
    Event Type
    Malfunction
    Date Received
    November 22, 2024
    Date of Event
    October 28, 2024
    Report Date
    April 11, 2025
    Manufacturer
    COLOPLAST A/S
    Product Code
    LJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REVIEW OF THE COMPLAINT HISTORY DATABASE, REVEALED NO TRENDS FOR THE LOT NUMBER 9571060. THE PRODUCT IS A SET. IT WAS COMPOSED WITH FOLLOWING COMPONENTS: - GUIDEWIRE: ITEM NUMBER SQ2246 LOT NUMBER 2305230374. - CHIBA NEEDLE 18G: ITEM NUMBER SS7203 LOT NUMBER 2302210082. - DILATOR CH6: ITEM NUMBER YD140670 LOT NUMBER 9075276, 9075277. - DILATOR CH8: ITEM NUMBER YD140870 LOT NUMBER 9450569. - J CATHETER: ITEM NUMBER YJ160870 LOT NUMBER 9202821, 9192147, 9192148. THE ISSUE DESCRIBE CONCERNED THE J CATHETER WHICH WAS MADE IN JUNE 2023. ACCORDING TO THE INFORMATION KNOWN QUALITY DATABASE WAS CHECKED AND REVEALED ONE NON-CONFORMITY OPENED IN OCTOBER 2024 FOR "MANDRIN STUCK IN THE VORTEK J CATHETER" POTENTIALLY RELATED TO THE COMPLAINT'S DESCRIPTION. 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 THE PRODUCT AND SAME DEFECT (FUNCTIONALITY MANDRIN STUCK) FROM OCTOBER 2020 TO OCTOBER 2024:19 SIMILAR CASE WERE FOUND. A RISK MANAGEMENT FILE EVALUATION WAS PERFORMED AND 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.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION, DURING INSTALLATION, THE WHITE ADAPTER DETACHED FROM THE STYLUS. IT WASN'T POSSIBLE TO REMOVE THE STYLET FROM THE CATHETER.

    Description of Event or Problem · 0

    ACCORDING TO THE ADDITIONAL INFORMATION, MOSQUITOS WERE USED TO REMOVE THE STYLET AND CONTINUE THE PROCEDURE WITH A DELAY. THE PATIENT EXPERIENCED DISCOMFORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1758743 PERCUTANEOUS NEPHROSTOMY SET WITH SIMPLE LOOP VORTEK CATHETER NEPHROSTOMY CATHETER LJE COLOPLAST A/S 9571060_RJE1081002

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown