BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTAREX

    MDR report key: 12363930 · Received August 25, 2021

    Report

    Report Number
    3008439199-2021-00137
    Event Type
    Malfunction
    Date Received
    August 25, 2021
    Date of Event
    July 28, 2021
    Report Date
    November 23, 2021
    Manufacturer
    UNKNOWN
    Product Code
    MCW
    PMA / PMN Number
    K172315
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 NOT RETURNED FOR EVALUATION. THEREFORE, THE INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED ISSUES. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON THE AVAILABLE INFORMATION. LABELING REVIEW: A REVIEW OF PRODUCT LABELING DOCUMENTATION (E.G., PROCEDURAL INSTRUCTIONS, INDICATIONS, WARNINGS, PRECAUTIONS, CAUTIONS, POSSIBLE COMPLICATIONS, CONTRAINDICATIONS, NURSING GUIDE, AND UNIT LABEL) DID NOT FIND ANY PRODUCT LABELING INADEQUACY. H10: D4 (EXPIRY DATE: 06/2040), H6 (DEVICE). H11: H6 (METHOD, RESULT, CONCLUSION). 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. H3 OTHER TEXT: DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE IN SUPERFICIAL FEMORAL ARTERY, THE DEVICE ALLEGEDLY BROKE. THE PROCEDURE WAS COMPLETED USING SAME DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

    Additional Manufacturer Narrative · 1

    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. THE MEDICAL DEVICE MANUFACTURER AND MANUFACTURING LOCATION FOR THE STRAUB PRODUCT WAS SELECTED AS UNKNOWN DUE TO SYSTEM LIMITATIONS. THE CORRECT MEDICAL DEVICE MANUFACTURER AND MANUFACTURING LOCATION ARE STRAUB MEDICAL US. (EXPIRY DATE: 06/2040).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, THE DEVICE ALLEGEDLY BROKE. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1262807 ROTAREX THROMBECTOMY & ATHERECTOMY MCW UNKNOWN 200136

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown