BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASPIREX

    MDR report key: 22165268 · Received June 9, 2025

    Report

    Report Number
    3008439199-2025-00125
    Event Type
    Malfunction
    Date Received
    June 9, 2025
    Date of Event
    May 14, 2025
    Report Date
    July 15, 2025
    Manufacturer
    STRAUB MEDICAL AG
    Product Code
    QEW
    UDI-DI
    07640142811350
    PMA / PMN Number
    K220270
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: 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, PHOTOS WERE PROVIDED FOR REVIEW. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. H11: D2B (QEW; DQX). H11: 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: 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: CATHETER WAS RETURNED FOR EVALUATION, AND A PHYSICAL INVESTIGATION WAS PERFORMED ON THE CATHETER. DURING PHYSICAL INVESTIGATION A HEAVY CLOGGED CATHETER WAS RECEIVED. THE TEST GUIDE WIRE WENT THROUGH THE CATHETER WITH SLIGHT RESISTANCE. THE ASPIRATION TEST WAS PERFORMED, AND NOMINAL ASPIRATION LEVEL WAS ACHIEVED. THEREFORE, THE RESULT OF THE INVESTIGATION IS NOT CONFIRMED FOR THE REPORTED FAILURE. 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. B5, D2B (QEW; DQX), G3, H6 (DEVICE, 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.

    Description of Event or Problem · 0

    ON (B)(6) 2025, A PATIENT UNDERWENT A RECANALIZATION PROCEDURE USING THE ASPIREX CATHETER. DURING THE PROCEDURE IN THE POPLITEAL VEIN VIA IPSILATERAL APPROACH, THE LARGE AMOUNT OF BLOOD COMING OUT THE BACK OF THE GREEN HANDLE. 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 IN POPLITEAL VEIN VIA IPSILATERAL. DURING THE PROCEDURE, THE LARGE AMOUNT OF BLOOD COMING OUT THE BACK OF THE GREEN HANDLE. A 6FR ASPIREX WAS USED AFTER AND STENT WAS LATER PLACED. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1333532 ASPIREX THROMBECTOMY & ATHERECTOMY QEW STRAUB MEDICAL AG 241189 07640142811350

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown