BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASPIREX

    MDR report key: 20223039 · Received September 16, 2024

    Report

    Report Number
    3008439199-2024-00163
    Event Type
    Malfunction
    Date Received
    September 16, 2024
    Date of Event
    August 20, 2024
    Report Date
    September 20, 2024
    Manufacturer
    STRAUB MEDICAL AG
    Product Code
    DQX
    UDI-DI
    07640142811350
    PMA / PMN Number
    K220270
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    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: THE CATHETER AND GUIDEWIRE WERE DELIVERED FOR EVALUATION AND PHYSICALLY INVESTIGATED. DURING PHYSICAL INVESTIGATION, THE GUIDE WIRE WAS BROKEN AT 123 CM FROM THE TIP OF IT. THE CATHETER WAS FOUND WITHOUT ANY DAMAGES. HELIX WAS VISIBLE IN THE WINDOW, WHICH LEADS TO THE ASSUMPTION THAT THE HELIX IS NOT BROKEN. ASPIRATION TEST WAS PERFORMED AND NOMINAL ASPIRATION LEVEL WAS ACHIEVED. THE REPORTED GUIDE WIRE BREAK CAN BE CONFIRMED. THEREFORE, THE INVESTIGATION IS CONFIRMED FOR THE REPORTED GUIDE WIRE BREAK ISSUE. A CLEAR ROOT CAUSE FOR THESE INCIDENTS COULD NOT BE IDENTIFIED BUT BREAK OF THE GUIDEWIRE 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. H10: D4 (EXPIRATION DATE: 08/2024), G3 H11: D2B (DQX;QEW), D4 (UNIQUE IDENTIFIER (UDI) #), H6 (METHOD, RESULT, CONCLUSION) 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. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. H10: D4 (EXPIRATION DATE: 08/2024). 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 PREPARATION FOR A THROMBECTOMY AND ATHERECTOMY PROCEDURE, WHILE SUBMERGING THE CATHETER IN THE BOWL OF SALINE TO PREPARE, THE CATHETER ALLEGEDLY CUT THE WIRE INTO TWO PIECES. THERE WAS NO PATIENT CONTACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PREPARATION FOR A THROMBECTOMY AND ATHERECTOMY PROCEDURE, WHILE SUBMERGING THE CATHETER IN THE BOWL OF SALINE TO PREPARE, THE CATHETER ALLEGEDLY CUT THE WIRE INTO TWO PIECES. THERE WAS NO PATIENT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1639012 ASPIREX THROMBECTOMY & ATHERECTOMY DQX STRAUB MEDICAL AG 221267 07640142811350

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown