BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASPIREX

    MDR report key: 24951689 · Received April 22, 2026

    Report

    Report Number
    3008439199-2026-00102
    Event Type
    Malfunction
    Date Received
    April 22, 2026
    Date of Event
    March 31, 2026
    Report Date
    April 3, 2026
    Manufacturer
    STRAUB MEDICAL AG
    Product Code
    DQX
    UDI-DI
    07640142811336
    PMA / PMN Number
    K220270
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE PERFORMED. THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. THEREFORE, THE INVESTIGATION OF THE REPORTED EVENT IS INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) ARE ADEQUATE FOR THE REPORTED DEVICE/PATIENT CODE(S) AND PROVIDES GENERAL INSTRUCTIONS FOR USE, AS WELL AS WARNINGS, PRECAUTIONS AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. UPON RECEIPT OF NEW OR ADDITIONAL INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPLICABLE. D2B (DQX; QEW) 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.

    Description of Event or Problem · 0

    A PATIENT UNDERWENT A THROMBECTOMY AND ATHERECTOMY PROCEDURE USING AN ASPIREX DEVICE. DURING THE PROCEDURE, THE DEVICE COULD NOT BE ADVANCED AND WITHDRAWN AS INTENDED, AND RESISTANCE WAS ENCOUNTERED. THE DEVICE WAS SUBSEQUENTLY REMOVED. THE PROCEDURE WAS THEN SUCCESSFULLY COMPLETED USING AN ALTERNATIVE DEVICE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1010631 ASPIREX THROMBECTOMY & ATHERECTOMY DQX STRAUB MEDICAL AG 240657 07640142811336

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown