BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASPIREX

    MDR report key: 19880585 · Received August 1, 2024

    Report

    Report Number
    3008439199-2024-00130
    Event Type
    Malfunction
    Date Received
    August 1, 2024
    Date of Event
    July 6, 2024
    Report Date
    September 5, 2024
    Manufacturer
    STRAUB MEDICAL AG
    Product Code
    QEW
    UDI-DI
    07640142810506
    PMA / PMN Number
    K220270
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: 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 OR PICTURES WERE RECEIVED. A PHYSICAL INVESTIGATION WAS NOT POSSIBLE. THE USER REPORT CONTAINS INFORMATION REGARDING CATHETER LEAKAGE. THE USER PROVIDED VIDEO SHOWS THE LEAKAGE OF THE CATHETER. AFTER REVIEW OF THE PROVIDED VIDEO THE REPORTED MALFUNCTION CAN BE CONFIRMED. THEREFORE, THE INVESTIGATION WAS CONFIRMED FOR LEAK ISSUE. 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. H11: 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

    H10: 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. HOWEVER, A PHOTO AND VIDEO WERE PROVIDED FOR REVIEW. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. H10: D4 (EXPIRY DATE: 11/2024) H11: 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

    IT WAS REPORTED THAT DURING A THROMBECTOMY AND ATHERECTOMY PROCEDURE VIA RIGHT LEG AT DEEP FEMORAL VEIN, THE HUB OF THE CATHETER HAD ALLEGEDLY LEAKED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A THROMBECTOMY AND ATHERECTOMY PROCEDURE, THE HUB OF THE CATHETER HAD ALLEGEDLY LEAKED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2248950 ASPIREX THROMBECTOMY & ATHERECTOMY QEW STRAUB MEDICAL AG 221696 07640142810506

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown