BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENOVOCATH RC 120

    MDR report key: 13935149 · Received March 29, 2022

    Report

    Report Number
    3011279674-2020-00001
    Event Type
    Injury
    Date Received
    March 29, 2022
    Date of Event
    June 12, 2020
    Report Date
    March 28, 2022
    Manufacturer
    RENOVORX, INC.
    Product Code
    MJN
    PMA / PMN Number
    K191606
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE PERFORMED AS INTENDED AND THEREFORE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION. A REVIEW OF LOT HISTORY RECORDS DID NOT REVEAL ANY ANOMALIES OF COMPONENTS OR MANUFACTURING THAT COULD HAVE CONTRIBUTED TO THIS EVENT. NOTE: THIS MDR WAS ORIGINALLY SUBMITTED ON JUNE 30, 2020. HOWEVER, THIS MDR IS BEING RESUBMITTED ON MARCH 28, 2022 BECAUSE AN INVESTIGATION DETERMINED THAT THE ORIGINAL SUBMISSION WAS NOT PROPERLY ACCEPTED IN THE PRODUCTION WEB TRADER ENVIRONMENT.

    Description of Event or Problem · 0

    PATIENT HAS LOCALLY ADVANCED PANCREATIC CANCER AND IS A PARTICIPANT IN A DRUG STUDY WHERE THE RENOVOCATH DEVICE IS USED TO DELIVER GEMCITABINE DIRECTLY TO THE PANCREATIC TUMOR. NO DEVICE MALFUNCTIONS OCCURRED THROUGHOUT THE PROCEDURE AND THE PATIENT WAS REPORTED TO HAVE TOLERATED THE PROCEDURE WELL. THE PROCEDURE WAS COMPLETED AS PLANNED WITHOUT INCIDENT OR COMPLICATION AND THE PATIENT WAS DISCHARGED HOME. THE FOLLOWING DAY THE PATIENT RETURNED TO THE ER WITH SYMPTOMS OF SEVERE ABDOMINAL PAIN ACCOMPANIED BY NAUSEA. CT SCAN DEMONSTRATED SUSPICION FOR NECROSIS IN THE MID JEJUNUM. THE PATIENT WAS EMERGENTLY TAKEN TO THE OR AND WAS FOUND TO HAVE A SHORT SEGMENT OF MID JEJUNUM THAT WAS ISCHEMIC. THE SURGERY INVOLVED RESECTION OF THE JEJUNUM. THE PATIENT'S POSTOPERATIVE COURSE WAS UNCOMPLICATED. HIS DIET WAS ADVANCED AND PATIENT WAS AMBULATING. PATIENT WAS GIVEN PROPHYLACTIC HEPARIN AND CAN RESTART HIS THERAPEUTIC LOVENOX ON DISCHARGE. ON DAY OF DISCHARGE, PATIENT WAS AMBULATING, VOIDING, HAVING BOWEL FUNCTION, TOLERATING PO INTAKE, AND PAIN WAS WELL CONTROLLED ON PO PAIN MEDICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640886 RENOVOCATH RC 120 VASCULAR CLAMP, PRODUCT CODE: MJN MJN RENOVORX, INC. MMRC 120-DB-1111 Z2458611A

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Hospitalization| R INTRA-ARTERIAL GEMCITIBINE TO TREAT PANCREATIC TUM