BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTAREX

    MDR report key: 21917192 · Received April 28, 2025

    Report

    Report Number
    3008439199-2025-00093
    Event Type
    Malfunction
    Date Received
    April 28, 2025
    Date of Event
    April 2, 2025
    Report Date
    June 10, 2025
    Manufacturer
    STRAUB MEDICAL AG
    Product Code
    MCW
    UDI-DI
    07640142810582
    PMA / PMN Number
    K211738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. THEREFORE, THE INVESTIGATION OF THE REPORTED EVENT IS INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) IS ADEQUATE FOR THE REPORTED DEVICE/PATIENT CODE(S) AND PROVIDES GENERAL INSTRUCTIONS FOR USE, AS WELL AS WARNINGS, PRECAUTIONS AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. UPON RECEIPT OF NEW OR ADDITIONAL INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPLICABLE. H11: D2B (MCW; DQX). 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 / IMAGES / VIDEOS WERE RECEIVED. A PHYSICAL INVESTIGATION WAS NOT POSSIBLE. DUE TO NO SAMPLE / IMAGES / VIDEOS RECEIVED, THE REPORTED MALFUNCTION CAN NOT BE CONFIRMED. 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. D2B (MCW; DQX), D4 (UNIQUE IDENTIFIER (UDI) #), G3, H6 (COMPONENT). 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

    ON (B)(6) 2025, A PATIENT UNDERWENT THROMBECTOMY AND ATHERECTOMY PROCEDURE USING ROTAREX CATHETER VIA COMMON FEMORAL ARTERY THROUGH CONTRALATERAL APPROACH. DURING THE PROCEDURE, HELIX WAS ALLEGEDLY FRACTURED IN AN IN-STENT RESTENOSIS CASE. FRACTURED HELIX WAS RETRIEVED AND REMOVED.

    Description of Event or Problem · 0

    ON (B)(6) 2025, A PATIENT UNDERWENT THROMBECTOMY AND ATHERECTOMY PROCEDURE USING ROTAREX CATHETER VIA COMMON FEMORAL ARTERY THROUGH CONTRALATERAL APPROACH. DURING THE PROCEDURE, HELIX WAS ALLEGEDLY FRACTURED IN AN IN-STENT RESTENOSIS CASE. FRACTURED HELIX WAS RETRIEVED AND REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1429417 ROTAREX THROMBECTOMY & ATHERECTOMY MCW STRAUB MEDICAL AG UNKNOWN 07640142810582

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown