BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENOVOCATH

    MDR report key: 14436399 · Received May 19, 2022

    Report

    Report Number
    3011279674-2022-00002
    Event Type
    Malfunction
    Date Received
    May 19, 2022
    Date of Event
    April 19, 2022
    Report Date
    May 17, 2022
    Manufacturer
    RENOVORX, INC.
    Product Code
    MJN
    PMA / PMN Number
    K21234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WE HAVE REQUESTED AND ARE AWAITING THE RETURN OF THE DEVICE TO COMPLETE OUR INVESTIGATION.

    Description of Event or Problem · 0

    THE RENOVOCATH IS ONLY USED FOR CLINICAL INVESTIGATIONS AT THIS TIME (TIGER-PAC CLINICAL STUDY). IT WAS REPORTED THAT THE PHYSICIAN "HAD A HARD TIME ADVANCING THE CATHETER AND THEN A HARD TIME REMOVING THE CATHETER. WHEN THEY WERE ABLE TO REMOVE THE CATHETER, THE DISTAL BALLOON DID NOT LOOK RIGHT AND HE DID NOT WANT TO RISK RUPTURE INSIDE THE PATIENT SO THEY OPENED ANOTHER CATHETER." A COPY OF THE MEDWATCH REPORT FILED BY THE HOSPITAL WAS RECEIVED ON 4/28/22 WHERE THE PROBLEM WAS DESCRIBED AS "PRIOR TO INSERTION OF BALLOON, CATHETER SHEARED OFF BECOMING UNUSABLE. NO HARM TO PATIENT." AT THIS TIME, WE HAVE BEEN UNABLE TO RESOLVE THE DISCREPANCY BETWEEN THE TWO REPORTS. IT WAS REPORTED THAT AN ADDITIONAL CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITHOUT FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1892685 RENOVOCATH OCCLUSION BALLOON CATHETER MJN RENOVORX, INC. MMRC120-DB-1111 Z2459460B

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male