BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTAREX

    MDR report key: 20083834 · Received August 28, 2024

    Report

    Report Number
    3008439199-2024-00149
    Event Type
    Malfunction
    Date Received
    August 28, 2024
    Date of Event
    July 26, 2024
    Report Date
    September 2, 2024
    Manufacturer
    STRAUB MEDICAL AG
    Product Code
    MCW
    UDI-DI
    07640142810582
    PMA / PMN Number
    K211738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 AND A PHYSICAL INVESTIGATION WAS PERFORMED FOR THE CATHETER. DURING PHYSICAL INVESTIGATION, THE TIP OF THE CATHETER WAS DETACHED FROM THE HELIX. THEREFORE, THE INVESTIGATION IS CONFIRMED FOR THE REPORTED HELIX DETACHMENT ISSUE. THE DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON PROVIDED INFORMATION. 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: 02/2027). H11: 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. HOWEVER, A PHOTO WAS PROVIDED FOR REVIEW. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. H10: D4 (EXPIRY DATE: 02/2027). 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 VIA THE LEFT COMMON FEMORAL ARTERY, THE CATHETER WAS ALLEGEDLY STUCK IN THE SHEATH APPROXIMATELY ONE-TWO CENTIMETERS ON THE WAY OUT OF THE PATIENT BODY. IT WAS FURTHER REPORTED THAT THE CATHETER ALLEGEDLY BROKE OFF. REPORTEDLY, THE BROKEN PART OF THE CATHETER WAS STUCK IN THE SHEATH AND REMOVED USING FILTER. THERE WAS NO REPORTED PATIENT INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A THROMBECTOMY AND ATHERECTOMY PROCEDURE VIA LEFT COMMON FEMORAL ARTERY, THE CATHETER WAS ALLEGEDLY STUCK IN THE SHEATH APPROXIMATELY ONE-TWO CENTIMETERS ON THE WAY OUT OF THE PATIENT BODY. IT WAS FURTHER REPORTED THAT THAT THE CATHETER ALLEGEDLY BROKE OFF. REPORTEDLY, THE BROKEN PART OF THE CATHETER WAS STUCK IN THE SHEATH AND REMOVED USING FILTER. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1494225 ROTAREX THROMBECTOMY & ATHERECTOMY MCW STRAUB MEDICAL AG 240769 07640142810582

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown