BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASPIREX

    MDR report key: 23829840 · Received December 17, 2025

    Report

    Report Number
    3008439199-2025-00310
    Event Type
    Malfunction
    Date Received
    December 17, 2025
    Date of Event
    November 20, 2025
    Report Date
    January 8, 2026
    Manufacturer
    STRAUB MEDICAL AG
    Product Code
    DQX
    UDI-DI
    07640142811350
    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 WAS PERFORMED. THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. D2B (DQX; QEW). SECTION A THROUGH F ¿ THE INFORMATION PROVIDED 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: 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: A PHYSICAL INVESTIGATION WAS PERFORMED FOR THE CATHETER AND THE GUIDEWIRE ANGLED. DURING PHYSICAL INVESTIGATION A CATHETER AND THE GUIDEWIRE INSIDE WERE RECEIVED. A CLOGGING OF THE CATHETER COULD APPEAR DUE TO A RESTRICTED FLOW OF FLUID INSIDE THE CATHETER, THAT CAN BE LEAD BACK TO AN INSUFFICIENT DOSAGE OF HEPARIN, TOO FAST ADVANCE OF THE CATHETER OR INSUFFICIENT ADDITION OF SALINE DURING TREATMENT. THE IFU DESCRIBES THE PROCEDURE FOR FLUSHING A CLOGGED CATHETER TO REESTABLISH FUNCTIONALITY. A CLEAR ROOT CAUSE COULD NOT BE IDENTIFIED BUT A BLOCKAGE OF THE 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 (DQX; QEW), G3, H6 (COMPONENT, RESULT, CONCLUSION). SECTION A THROUGH F ¿ THE INFORMATION PROVIDED 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

    ON (B)(6) 2025, A PATIENT UNDERWENT A RECANALIZATION PROCEDURE USING THE ASPIREX CATHETER. DURING PROCEDURE, IT WAS REPORTED THAT THE GUIDEWIRE WAS CAUGHT INSIDE THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

    Description of Event or Problem · 0

    ON (B)(6) 2025, A PATIENT UNDERWENT A RECANALIZATION PROCEDURE USING THE ASPIREX CATHETER. DURING PROCEDURE, IT WAS REPORTED THAT THE GUIDEWIRE WAS CAUGHT INSIDE THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2186453 ASPIREX THROMBECTOMY & ATHERECTOMY DQX STRAUB MEDICAL AG 241558 07640142811350

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown