BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENOVOCATH RC120

    MDR report key: 14107995 · Received April 13, 2022

    Report

    Report Number
    3011279674-2016-00001
    Event Type
    Malfunction
    Date Received
    April 13, 2022
    Date of Event
    November 10, 2016
    Report Date
    April 13, 2022
    Manufacturer
    RENOVORX, INC.
    Product Code
    MJN
    PMA / PMN Number
    K141175
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED AND THEREFORE A PHYSICAL EXAMINATION OF THE FAILED DEVICE WAS NOT POSSIBLE. A REVIEW OF THE LOT HISTORY RECORD DID NOT REVEAL ANY ISSUES RELEVANT TO DETACHMENT OF THE TIP. BASED ON THE DESCRIPTION OF THE EVENT, IT IS BELIEVED THAT THE OPERATOR DID NOT SUFFICIENTLY FLUSH THE DEVICE BEFORE USE, CAUSING THE GUIDEWIRE TO BECOME STUCK. A REVIEW OF THE IFU REVEALED THE INSTRUCTIONS ADEQUATELY ADDRESS FLUSHING OF THE GUIDEWIRE LUMEN WITH SALINE PRIOR TO USE. THE OPERATOR WAS RETRAINED TO THE IFU. THIS IS THE FIRST COMPLAINT OF TIPPED ATTACHMENT EVER RECEIVED BY THE MANUFACTURER. THE MANUFACTURER WILL CONTINUE TO TRACK AND TREND FOR THIS EVENT. THE ROOT CAUSE HAS BEEN ASSIGNED AS USER ERROR. NOTE: THIS MDR WAS ORIGINALLY SUBMITTED IN PAPER FORM ON (B)(6) 2016. HOWEVER, THIS MDR IS BEING RESUBMITTED ON (B)(6) 2022 BECAUSE AN INVESTIGATION DETERMINED THAT THE ORIGINAL PAPER SUBMISSION WAS NOT PROPERLY RECEIVED AND ACCEPTED.

    Description of Event or Problem · 0

    THERE WAS SOME DIFFICULTY ADVANCING THE CATHETER IN MILD TORTUOSITY IN HEPATIC ARTERY. CATHETER BUCKLED AND BECAME STUCK ON THE ABBOTT VASCULAR IRON MAN GUIDEWIRE. UPON EXERTING FORCE TO REMOVE THE CATHETER, THE DISTAL TIP SHEARED OFF AND BECAME SEPARATED FROM THE REST OF THE CATHETER. ATTEMPTS TO SNARE THE TIP WERE UNSUCCESSFUL. PATIENT WAS ADMITTED TO THE HOSPITAL FOR PAIN WITHIN 24 HOURS OF THE PROCEDURE. THE SITE OF THE PROCEDURE WAS FOUND RE-CANNALIZED WITH GOOD FLOW TO THE LIVER. NO ADDITIONAL AE REPORTED. PAIN RESOLVED AND PATIENT WAS DISCHARGED WITHIN 24 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2669714 RENOVOCATH RC120 VASCULAR CLAMP MJN RENOVORX, INC. MMRC120-DB-1111 B2457245A

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Hospitalization