BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTAREX

    MDR report key: 22910434 · Received August 28, 2025

    Report

    Report Number
    3008439199-2025-00196
    Event Type
    Malfunction
    Date Received
    August 28, 2025
    Date of Event
    July 25, 2025
    Report Date
    September 24, 2025
    Manufacturer
    STRAUB MEDICAL AG
    Product Code
    MCW
    UDI-DI
    07640142811862
    PMA / PMN Number
    K211738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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: NO PHYSICAL SAMPLE WAS RECEIVED. A PHYSICAL INVESTIGATION WAS NOT POSSIBLE. THE USER REPORT AND THE PROVIDED IMAGE CONTAIN INFORMATION REGARDING CATHETER MECHANICAL JAM. AFTER REVIEW OF THE PROVIDED IMAGE MECHANICAL JAM CAN NOT BE CONFIRMED. A CLEAR ROOT CAUSE COULD NOT BE ESTABLISHED. LABELING REVIEW: AS THE REPORTED EVENT DID NOT ALLEGE A LABELING OR USE RELATED ISSUE, A LABELING REVIEW IS NOT REQUIRED. D2B (DQX; MCW), D4 (UNIQUE IDENTIFIER (UDI) #), G3, H6 (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 DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. HOWEVER, PHOTO WAS PROVIDED FOR REVIEW. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. D2B: DQX;MCW 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

    A PATIENT UNDERWENT A THROMBECTOMY & ATHERECTOMY PROCEDURE USING ROTAREX. DURING THE PROCEDURE, WHEN TRYING TO FLUSH/PRIME THE CATHETER NO FLUID APPEARED IN THE HAND PIECE, ALLEGEDLY THE CATHETER WAS NOT WORKING/ASPIRATING. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT CONTACT.

    Description of Event or Problem · 0

    A PATIENT UNDERWENT A THROMBECTOMY & ATHERECTOMY PROCEDURE, DURING THE PROCEDURE, WHEN TRYING TO FLUSH/PRIME THE CATHETER NO FLUID APPEARED IN THE HAND PIECE, ALLEGEDLY THE CATHETER WAS NOT WORKING/ASPIRATING. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1519714 ROTAREX THROMBECTOMY & ATHERECTOMY MCW STRAUB MEDICAL AG 242693 07640142811862

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown