BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENOVOCATH RC 120

    MDR report key: 13935207 · Received March 29, 2022

    Report

    Report Number
    3011279674-2019-00001
    Event Type
    Injury
    Date Received
    March 29, 2022
    Date of Event
    July 31, 2019
    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
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR INSPECTION. A REVIEW OF LOT HISTORY RECORDS DID NOT REVEAL ANY ISSUES THAT MIGHT HAVE CAUSED OR CONTRIBUTED TO THE ADVERSE OUTCOME. THE LABELING WAS REVIEWED AND FOUND TO CONTAIN THE APPROPRIATE DIRECTIONS AND CAUTIONS. A REVIEW OF THE LITERATURE DESCRIBES A 0.9% OF THROMBOTIC EVENTS FOR RELATED PROCEDURES. RENOVORX WILL CONTINUE TO TRACK AND TREND FOR ADVERSE EVENTS AS PART OF POST MARKET SURVEILLANCE. THIS MDR WAS ORIGINALLY SUBMITTED ON AUGUST 30, 2019. 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 WEBTRADER ENVIRONMENT.

    Description of Event or Problem · 0

    THE PATIENT IS ENROLLED IN A CLINICAL DRUG STUDY. THE PATIENT RECEIVED INTRA-ARTERIAL CHEMOTHERAPY (GEMCITIBINE)TO TREAT A PANCREATIC TUMOR. THE RENOVOCATH WAS USED TO DELIVER THE DRUG DIRECTLY TO THE SPLENIC ARTERY, PROXIMAL TO THE TUMOR. THE DEVICE WAS INSERTED INTO THE LEFT UPPER BRACHIAL/AXILLARY ARTERY THROUGH 65 CM TERUMO SHEATH. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE DRUG INFUSION LASTED 23 MINUTES. WITHIN AN HOUR OF THE PROCEDURE THE PATIENT COMPLAINED OF PAIN AND BLUE FINGERTIPS TO 1ST AND 2ND DIGIT ON LEFT HAND. ON EXAMINATION THE PATIENT HAD A PALABLE AXILLARY PULSE BUT NO BRACHIAL/RADIAL PULSES. A VASULAR SURGEON WAS CONSULTED AND THE PATIENT WAS SENT TO OR FOR AN OPEN THROMBECTOMY, PROXIMAL TO THE ACCESS SITE, INCISION WAS APPROXIMATELY 5CM AND APPROXIMATELY 3 CM OF THROMBUS WAS EXTRACTED. POST-PROCEDURE, THE PATIENT HAD 2+ LEFT RADIAL PULSE, COLOR HAD RETURNED AND ALL SENSATIONS WERE INTACT. THE PATIENT TOLERATED THE PROCEDURE WELL WITH NO FURTHER COMPLICATIONS. SHE WAS DISCHARGED HOME ON (B)(6) 2019. NOTE: ~ 6-7 CM OF SPARE CATHETER LENGTH USING THE TERUMO PINNACLE DESTINATION 65CM 6F SHEATH STRAIGHT WITH TUOHY-BORST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534779 RENOVOCATH RC 120 CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY MJN RENOVORX, INC. MMRC120-DB-1111 Z2458508B

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Hospitalization| O TERUMO SHEATH, 65 CM.LOSARTAN 100 MG BIDPANCRELI