BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTAREX SET 6F 135CM

    MDR report key: 12203058 · Received July 21, 2021

    Report

    Report Number
    3008439199-2021-00119
    Event Type
    Malfunction
    Date Received
    July 21, 2021
    Date of Event
    June 22, 2021
    Report Date
    October 29, 2021
    Manufacturer
    UNKNOWN
    Product Code
    MCW
    PMA / PMN Number
    K172315
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    003

    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 RETURNED FOR EVALUATION. THE HELIX WAS BROKEN AT 20 CM DISTAL. THEREFORE, THE INVESTIGATION IS CONFIRMED FOR THE REPORTED ISSUE. THE DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON 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. 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 THE PROCEDURE, THE HELIX OF CATHETER WAS ALLEGEDLY SEPARATED WHILE IN PATIENT. IT WAS FURTHER REPORTED THAT THE DETACHED SEGMENT WAS REMOVED WITH SNARE. 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. (EXPIRY DATE: 06/2040).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, THE HELIX OF CATHETER WAS ALLEGEDLY SEPARATED WHILE IN PATIENT. THE PROCEDURE WAS COMPLETED USING A SNARE. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1099939 ROTAREX SET 6F 135CM THROMBECTOMY & ATHERECTOMY MCW UNKNOWN 200475

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other