BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASPIREX

    MDR report key: 19094123 · Received April 11, 2024

    Report

    Report Number
    3008439199-2024-00061
    Event Type
    Injury
    Date Received
    April 11, 2024
    Date of Event
    March 19, 2024
    Report Date
    March 27, 2026
    Manufacturer
    STRAUB MEDICAL AG
    Product Code
    DQX
    UDI-DI
    07640142811343
    PMA / PMN Number
    K220270
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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 CATHETER AND THE GUIDEWIRE WERE PHYSICALLY INVESTIGATED. THE REPORTED GUIDEWIRE BREAK AND MECHANICAL JAM CAN BE CONFIRMED. DURING PHYSICAL INVESTIGATION THE GUIDEWIRE WAS DELIVERED INSIDE OF THE CATHETER. THE GUIDEWIRE WAS STUCK WITH COAGULATED MATERIAL INSIDE OF THE CATHETER. THE FLEXIBLE TIP AND FOLLOWING PART THE GUIDEWIRE 78 CM WERE BROKEN OFF AND NOT DELIVERED. AFTER WORKING IN THE WATER SLIGHTLY LOWER THAN NOMINAL ASPIRATION LEVEL WAS ACHIEVED. NO FURTHER DAMAGE WAS NOTED. 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. D2B (QEW, DQX), B5, G2, G3, H6 (DEVICE, COMPONENT, RESULT). 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. H3 OTHER TEXT: DEVICE PENDING RETURN.

    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: A CATHETER AND THE GUIDEWIRE WERE PHYSICALLY INVESTIGATED. THE REPORTED GUIDEWIRE BREAK AND MECHANICAL JAM CAN BE CONFIRMED. DURING PHYSICAL INVESTIGATION THE GUIDEWIRE WAS DELIVERED INSIDE OF THE CATHETER. THE GUIDEWIRE WAS STUCK WITH COAGULATED MATERIAL INSIDE OF THE CATHETER. THE FLEXIBLE TIP AND FOLLOWING PART THE GUIDEWIRE 78 CM WERE BROKEN OFF AND NOT DELIVERED. AFTER WORKING IN THE WATER SLIGHTLY LOWER THAN NOMINAL ASPIRATION LEVEL WAS ACHIEVED. NO FURTHER DAMAGE WAS NOTED. 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, H6 (DEVICE). H11: B5, 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.

    Description of Event or Problem · 0

    ON (B)(6) 2024, A PATIENT UNDERWENT A THROMBECTOMY AND ATHERECTOMY PROCEDURE TO TREAT A LEFT ARTERIOVENOUS GRAFT DE CLOT TO BE ABLE TO USE FOR DIALYSIS. DURING THE PROCEDURE, IT WAS REPORTED THAT THE GUIDEWIRE WAS ALLEGEDLY GETTING HOT AND THERE WAS NO FLOW GOING INTO THE COLLECTION BAG. IT WAS FURTHER REPORTED THAT THE GUIDEWIRE AND THE CATHETER WERE REMOVED AS ONE UNIT SINCE THE GUIDEWIRE WAS FUSED INSIDE THE CATHETER. HOWEVER, DURING THE REMOVAL PROCESS THIRTY TO FORTY CENTIMETERS OF GUIDEWIRE FRACTURED OFF AND WAS IDENTIFIED CENTRALLY IN THE PATIENT'S RIGHT ATRIUM AND RIGHT VENTRICLE OF THE HEART. THE GUIDEWIRE WAS SNARED BUT A FLOPPY TIP BROKEN OFF AND REMAINS IN THE PATIENT'S HEART. THE PATIENT IS STABLE AND WAS ASYMPTOMATIC DURING THE ENTIRE PROCEDURE. THE CASE RESUMED AS NORMAL AND A SUCCESSFUL THROMBECTOMY WAS PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, THE WIRE WAS ALLEGEDLY GETTING HOT AND THERE WAS NO FLOW INTO THE COLLECTION BAG. IT WAS FURTHER REPORTED THAT WHEN ATTEMPTING TO REMOVE THE CATHETER OFF OF THE WIRE, THE CATHETER ALLEGEDLY COULD NOT BE REMOVED AS THE WIRE WAS FUSED INSIDE THE CATHETER. FURTHERMORE, ABOUT THIRTY TO FORTY CENTIMETERS OF THE WIRE WAS ALLEGEDLY FRACTURED OFF IN THE PATIENT'S RIGHT ATRIUM AND RIGHT VENTRICLE OF THE HEART. REPORTEDLY, THE FRACTURED PORTION OF THE WIRE WAS REMOVED WITH A SNARE DEVICE, BUT THE FLOPPY TIP OF THE WIRE ALLEGEDLY BROKE OFF UPON REMOVAL OF THE SNARED WIRE AND UNABLE TO BE RETRIEVED FROM THE PATIENT'S HEART. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A THROMBECTOMY AND ATHERECTOMY PROCEDURE TO TREAT A LEFT ARTERIOVENOUS GRAFT DE-CLOT TO BE ABLE TO USE FOR DIALYSIS, THE GUIDEWIRE WAS ALLEGEDLY GETTING HOT AND THERE WAS NO FLOW GOING INTO THE COLLECTION BAG. IT WAS FURTHER REPORTED THAT THE GUIDEWIRE AND THE CATHETER WERE REMOVED AS ONE UNIT SINCE THE GUIDEWIRE WAS FUSED INSIDE THE CATHETER; HOWEVER, DURING THE REMOVAL PROCESS THIRTY TO FORTY CENTIMETERS OF GUIDEWIRE FRACTURED OFF AND WAS IDENTIFIED CENTRALLY IN THE PATIENT'S RIGHT ATRIUM AND RIGHT VENTRICLE OF THE HEART. THE GUIDEWIRE WAS SNARED BUT A FLOPPY TIP BROKEN OFF AND REMAINS IN THE PATIENT'S HEART. THE PATIENT IS STABLE AND WAS ASYMPTOMATIC DURING THE ENTIRE PROCEDURE. THE CASE RESUMED AS NORMAL AND A SUCCESSFUL THROMBECTOMY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478760 ASPIREX THROMBECTOMY & ATHERECTOMY DQX STRAUB MEDICAL AG 220775 07640142811343

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Required Intervention