BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTAREX

    MDR report key: 22530589 · Received July 17, 2025

    Report

    Report Number
    3008439199-2025-00159
    Event Type
    Malfunction
    Date Received
    July 17, 2025
    Date of Event
    June 20, 2025
    Report Date
    August 27, 2025
    Manufacturer
    STRAUB MEDICAL AG
    Product Code
    MCW
    UDI-DI
    07640142811862
    PMA / PMN Number
    K211738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: MANUFACTURING REVIEW: A MANUFACTURING REVIEW WAS CONDUCTED AND THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. INVESTIGATION SUMMARY: THE PHYSICAL SAMPLE WAS RETURNED FOR EVALUATION AND A CATHETER WITH A BROKEN HELIX OUTSIDE OF THE TUBE WAS PHYSICALLY INVESTIGATED. DURING PHYSICAL INVESTIGATION, THE HELIX WAS FOUND BROKEN AT 18 CM FROM THE TIP OF THE CATHETER. A CLEAR ROOT CAUSE COULD NOT BE IDENTIFIED BUT A DAMAGED CATHETER REPRESENTS A KNOWN INHERENT RISK. LABELING REVIEW: AS THE REPORTED EVENT DID NOT ALLEGE A LABELING OR USE RELATED ISSUE, A LABELING REVIEW IS NOT REQUIRED. D2B (MCW; DQX), E1, G2, G3, H6 (COMPONENT, METHOD, RESULT, CONCLUSION). SECTION A THROUGH F: THE INFORMATION PROVIDE BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Additional Manufacturer Narrative · 0

    H11: AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE RETURN OF THE SAMPLE IS PENDING. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. D2B (MCW; DQX). SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Description of Event or Problem · 0

    ON (B)(6) 2025, A PATIENT UNDERWENT A THROMBECTOMY AND ATHERECTOMY PROCEDURE USING THE ROTAREX DEVICE. DURING THE PREPARATION, THE HELIX ALLEGEDLY FRACTURED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

    Description of Event or Problem · 0

    ON (B)(6) 2025, A PATIENT UNDERWENT A THROMBECTOMY AND ATHERECTOMY PROCEDURE USING THE ROTAREX DEVICE. DURING THE PREPARATION, THE HELIX ALLEGEDLY FRACTURED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    807656 ROTAREX THROMBECTOMY & ATHERECTOMY MCW STRAUB MEDICAL AG 250753 07640142811862

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown