BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTAREXS 6F 135CM (STRAUB MEDICAL)

    MDR report key: 10998943 · Received December 13, 2020

    Report

    Report Number
    3008439199-2020-00065
    Event Type
    Malfunction
    Date Received
    December 13, 2020
    Date of Event
    November 16, 2020
    Report Date
    November 17, 2020
    Manufacturer
    STRAUB MEDICAL AG
    Product Code
    MCW
    UDI-DI
    07640142810582
    PMA / PMN Number
    K172315
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION PROTOCOL NOT COMPLETED YET.

    Description of Event or Problem · 1

    ACCESS WAS OBTAINED WITH ULTRASOUND AND A MICRO PUNCTURE KIT VIA THE LEFT FEMORAL ARTERY. A 150CM STANDARD J WIRE WAS INTRODUCED INTO THE MICRO PUNCTURE SHEATH, AND THEN THE MICRO PUNCTURE SHEATH WAS REPLACED WITH A 6F 10CM PINNACLE SHEATH. AN AORTAGRAM WITH RUNOFF WAS PERFORMED WITH A PIGTAIL CATHETER. A NONCALCIFIC RIGHT ECCENTRIC SFA LESION WAS IDENTIFIED. COLLECTIVELY WE THEN DECIDED THAT THE BIFURCATION WAS VERY FAVORABLE FOR ROTAREX, AND THEN THE PHYSICIAN EXCHANGED THE 6F PINNACLE SHEATH WITH A 6FX45CM COOK HIGH FLEX ANSEL SHEATH. WE THEN USED A MULTIPURPOSE CATHETER AND 300CM GLIDE WIRE TO CROSS THE LESION, AND THE PHYSICIAN THEN EXCHANGED THE GLIDE WIRE FOR THE STRAUB .018 ROTAREX WIRE. WE THEN SELECTED A 6FX135CM ROTAREX, AND WE TOOK THE PROPER STEPS WITH DEVICE PREP. THE DEVICE WAS ADVANCED OVER THE ROTAREX WIRE THROUGH THE COOK HIGH FLEX ANSEL SHEATH 1CM PROXIMAL TO OUR TARGET LESION. THE PHYSICIAN THEN PERFORMED TWO THERAPEUTIC PASSES WITH THE DEVICE. THE DEVICE PERFORMED OPTIMAL WITH NO ALARMING CHANGES IN AUDIBLE PITCH. THE PHYSICIAN THEN DECIDED THAT HE PROVIDED ADEQUATE TREATMENT AND DECIDED TO REMOVE THE DEVICE. WE INFORMED THE PHYSICIAN THAT THE TIP OF THE ROTAREX CATHETER WILL LIKELY SEPARATE UPON REMOVAL FROM THE SHEATH AND THAT THIS IS NOT UNCOMMON. UPON REMOVAL THE ROTAREX TIP WAS HUNG UP IN THE VALVE OF THE COOK HIGH FLEX ANSEL SHEATH AND THE HELIX WAS STRETCHED TOO FAR CAUSING A FRACTURE OF THE HELIX. ADJUNCTIVE THERAPY WAS PERFORMED WITH A 5MMX150MM ULTRASCORE BALLOON WHICH OBTAINED SATISFACTORY ANGIOGRAPHIC RESULTS. THE COOK HIGH FLEX ANSEL SHEATH WAS REMOVED AND THE LEFT FEMORAL ARTERY PUNCTURE SITE WAS CLOSED WITH A MYNX CLOSURE DEVICE AND MANUAL PRESSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1462242 ROTAREXS 6F 135CM (STRAUB MEDICAL) ATHERECTOMY CATHETER MCW STRAUB MEDICAL AG SET ROTAREX®S 6F X 135CM 200664 07640142810582

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR