BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTAREX

    MDR report key: 20244682 · Received September 18, 2024

    Report

    Report Number
    3008439199-2024-00167
    Event Type
    Malfunction
    Date Received
    September 18, 2024
    Date of Event
    August 22, 2024
    Report Date
    August 19, 2025
    Manufacturer
    STRAUB MEDICAL AG
    Product Code
    MCW
    UDI-DI
    07640142811862
    PMA / PMN Number
    K211738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 PHYSICAL SAMPLE WAS NOT RETURNED FOR EVALUATION AND A PHYSICAL INVESTIGATION WAS NOT POSSIBLE. NO PICTURES OR VIDEOS WERE RECEIVED FOR REVIEW. HE USER REPORTED PROVIDED INFORMATION CONTAINS REGARDING COLLECTING BAG ISSUES. DUE TO NO SAMPLE/IMAGES/VIDEOS PROVIDED THE REPORTED MALFUNCTION CAN NOT BE CONFIRMED. THEREFORE, THE INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED BREAK ISSUE. A CLEAR ROOT CAUSE COULD NOT BE IDENTIFIED BUT A BLOCKAGE OF THE CATHETER REPRESENTS A KNOWN INHERENT RISK. LABELING REVIEW: 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. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. H10: D4 (EXPIRY DATE: 03/2027). 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: NO PHYSICAL SAMPLE OR PICTURES/VIDEOS WERE RECEIVED. A PHYSICAL INVESTIGATION WAS NOT POSSIBLE. THE USER REPORTED PROVIDED INFORMATION CONTAINS REGARDING COLLECTING BAG ISSUES. DUE TO NO SAMPLE/IMAGES/VIDEOS PROVIDED THE REPORTED MALFUNCTION CAN NOT BE CONFIRMED. A CLEAR ROOT CAUSE COULD NOT BE IDENTIFIED BUT A DAMAGED COLLECTING BAG 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 (MCW; DQX), D4 (UNIQUE IDENTIFIER (UDI) #), E1, G3. 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

    IT WAS REPORTED THAT DURING A THROMBECTOMY AND ATHERECTOMY PROCEDURE IN THE OCCLUDED DISTAL SUPERFICIAL FEMORAL ARTERY VIA THE TIBIAL ACCESS, THE COLLECTION BAG HAD ALLEGEDLY BROKEN WHILE STRETCHING THE TUBING OUT. IT WAS FURTHER THAT THE CLEAR TUBING WAS ALLEGEDLY FOUND TO BE YELLOWED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING RECANALIZATION PROCEDURE IN OCCLUDED DISTAL SUPERFICIAL ARTERY, THE COLLECTION BAG ALLEGEDLY HAD BROKEN WHILE STRETCHING TUBING OUT. IT WAS FURTHER THAT CLEAR TUBING WAS YELLOWED WAS FOUND. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

    Description of Event or Problem · 0

    ON (B)(6) 2024, A PATIENT UNDERWENT FOR THROMBECTOMY AND ATHERECTOMY PROCEDURE USING ROTAREX. IT WAS REPORTED THAT DURING PROCEDURE IN OCCLUDED DISTAL SUPERFICIAL FEMORAL ARTERY, THE COLLECTION BAG ALLEGEDLY HAD BROKEN WHILE STRETCHING TUBING OUT. IT WAS FURTHER REPORTED THAT THE CLEAR TUBING WAS YELLOWED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1067118 ROTAREX THROMBECTOMY & ATHERECTOMY MCW STRAUB MEDICAL AG 241119 07640142811862

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown