BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTAREX

    MDR report key: 18422818 · Received December 30, 2023

    Report

    Report Number
    3008439199-2023-00231
    Event Type
    Injury
    Date Received
    December 30, 2023
    Date of Event
    December 13, 2023
    Report Date
    February 8, 2024
    Manufacturer
    UNKNOWN
    Product Code
    MCW
    PMA / PMN Number
    K211738
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: THE CATALOG NUMBER IDENTIFIED IN SECTION D4 HAS NOT BEEN CLEARED IN THE US BUT IS SIMILAR TO THE ROTAREX THAT ARE CLEARED IN THE US. THE PRO CODE AND 510 K NUMBER FOR THE ROTAREX ARE IDENTIFIED IN D2 AND G4. H10: THE MEDICAL DEVICE MANUFACTURER (D3) AND MANUFACTURING LOCATION (G1) FOR THE STRAUB PRODUCT WAS SELECTED AS UNKNOWN DUE TO SYSTEM LIMITATIONS. THE CORRECT MEDICAL DEVICE MANUFACTURER AND MANUFACTURING LOCATION ARE STRAUB MEDICAL US. 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, IMAGES WERE PROVIDED FOR REVIEW. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. 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.

    Additional Manufacturer Narrative · 0

    H10: THE CATALOG NUMBER IDENTIFIED IN SECTION D4 HAS NOT BEEN CLEARED IN THE US BUT IS SIMILAR TO THE ROTAREX THAT ARE CLEARED IN THE US. THE PRO CODE AND 510 K NUMBER FOR THE ROTAREX ARE IDENTIFIED IN D2 AND G4. H10: THE MEDICAL DEVICE MANUFACTURER (D3) AND MANUFACTURING LOCATION (G1) FOR THE STRAUB PRODUCT WAS SELECTED AS UNKNOWN DUE TO SYSTEM LIMITATIONS. THE CORRECT MEDICAL DEVICE MANUFACTURER AND MANUFACTURING LOCATION ARE STRAUB MEDICAL US. 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 SAMPLE WAS RETURNED FOR EVALUATION. A CATHETER WAS PHYSICALLY INVESTIGATED. DURING PHYSICAL INVESTIGATION THE TEST GUIDEWIRE DID NOT PASS THROUGH THE METAL GEARWHEEL EVEN AFTER FLUSHING. AFTER RUNNING IN THE WATER NOMINAL ASPIRATION LEVEL WAS ACHIEVED. MECHANICAL JAM OF THE CATHETER WAS OBSERVED DURING PHYSICAL INVESTIGATION. THEREFORE, THE REPORTED RETRACTION PROBLEM CAN NOT BE CONFIRMED AND THE INVESTIGATION IS CONFIRMED FOR THE IDENTIFIED MECHANICAL JAM 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 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 RECANALIZATION PROCEDURE, THE CATHETER ALLEGEDLY GOT STOCKED INSIDE THE VESSEL WITH THE MOTOR ON AND WAS RETRACTED TOGETHER WITH THE WIRE. IT WAS FURTHER REPORTED THAT THE PATIENT ALLEGEDLY EXPERIENCED BLEEDING DUE TO VESSEL RUPTURE. REPORTEDLY, THE PATIENT UNDERWENT SURGICAL P3-BYPASS PROCEDURE FOR TREATMENT. THE PATIENT IS STABLE NOW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, THE CATHETER ALLEGEDLY GOT STOCKED INSIDE THE VESSEL WITH THE MOTOR ON AND WAS RETRACTED TOGETHER WITH THE WIRE. IT WAS FURTHER REPORTED THAT THE PATIENT ALLEGEDLY EXPERIENCED BLEEDING DUE TO VESSEL RUPTURE. REPORTEDLY, THE PATIENT UNDERWENT SURGICAL P3-BYPASS PROCEDURE FOR TREATMENT. THE PATIENT IS STABLE NOW..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2285803 ROTAREX THROMBECTOMY & ATHERECTOMY MCW UNKNOWN 231084

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention