BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTAREX

    MDR report key: 20143327 · Received September 5, 2024

    Report

    Report Number
    3008439199-2024-00154
    Event Type
    Malfunction
    Date Received
    September 5, 2024
    Date of Event
    July 18, 2024
    Report Date
    August 30, 2024
    Manufacturer
    STRAUB MEDICAL AG
    Product Code
    MCW
    UDI-DI
    07640142810582
    PMA / PMN Number
    K211738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 WAS RETURNED FOR EVALUATION. A PHYSICAL INVESTIGATION WAS PERFORMED FOR THE CATHETER. DURING PHYSICAL INVESTIGATION THE HELIX WAS BROKEN AT 52 CM DISTANCE FROM THE TIP OF THE CATHETER. THE BROKEN PART OF THE HELIX WAS SENT OUTSIDE OF THE CATHETER THE COLLECTING BAG WAS ALSO ATTACHED TO IT. THE TUBE HAD A HOLE AT 61CM FROM THE TIP OF THE CATHETER. AFTER OPENING THE CATHETER ANOTHER 9 CM OF BROKEN HELIX WAS WINDED UP TO THE HANDLE. THEREFORE, THE INVESTIGATION IS CONFIRMED FOR THE REPORTED HELIX BREAK. A CLEAR ROOT CAUSE COULD NOT BE ESTABLISHED. LABELING REVIEW: AS THE REPORTED EVENT DID NOT ALLEGE A LABELING OR USE RELATED ISSUE, A LABELING REVIEW IS NOT REQUIRED. H10: (EXPIRY DATE: 03/2027). H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF 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 IN THE DISTAL SUPERIOR FEMORAL ARTERY, THE CATHETER ALLEGEDLY BECAME STUCK IN CALCIUM PLAQUE AND DID NOT APPEAR TO BE SUCTIONING. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1341800 ROTAREX THROMBECTOMY & ATHERECTOMY MCW STRAUB MEDICAL AG 241074 07640142810582

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown