BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTAREXS 8F 110CM (STRAUB MEDICAL)

    MDR report key: 10230938 · Received July 4, 2020

    Report

    Report Number
    3008439199-2020-00012
    Event Type
    Malfunction
    Date Received
    July 4, 2020
    Date of Event
    May 15, 2020
    Report Date
    June 10, 2020
    Manufacturer
    STRAUB MEDICAL AG
    Product Code
    MCW
    UDI-DI
    07640142810391
    PMA / PMN Number
    K172315
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY SIGNED ON 08/07/2020 ATTACHED.

    Additional Manufacturer Narrative · 1

    SUSPECT DEVICE NOT RETURNED YET. THE RETURN OF THE SUSPECT DEVICE IS EXPECTED.

    Description of Event or Problem · 1

    IT WAS USED A WIRE INTRODUCER SHEATH 9F 70 CM, CONTRALATERAL. IT WAS DONE THE NECESSARY WASHES IN THE CATHETER WITH SALINE, PASSING THE GUIDE WIRE 0,018 OF THE SET. IT WAS PASSED THE CATHETER BY THE GUIDE WIRE, PASSING THE INTRODUCER WITHOUT ANY RESISTENCE. IN THE MOMENT OF TO REMOVE THE CATHETER FORM THE PATIENT, THE PHYSICIAN FELT A SLIGHT RESISTENCE. HE CHECKED THE CATHETER AFTER TO REMOVE FROM THE SHEATH. THE HELIX WAS COVERED BUT WHEN THE PHYSICIAN PULLED THE TIPO OF THE CATHETER, HE NOTED THAT THE HELIX WAS EXPOSED MORE THAT THE NORMAL. THEN HE OPTED TO USE ANOTHER CATHETER WITH THE SAME SIZE AND LOT 191293 AND REF 80224. WHEN THIS SECOND CATHETER WAS USED, THE PHISICIAN NOTED THAT THE CATHETER LOCKED, BUT THE PROCEDURE WAS FINALIZED. THE DETAILS OF THIS SECOND CATHETER WAS DESCRIBED IN A NEW COMPLAINT FORM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694932 ROTAREXS 8F 110CM (STRAUB MEDICAL) ATHERECTOMY CATHETER MCW STRAUB MEDICAL AG SET ROTAREX®S 8F X 110CM 191068 07640142810391

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR