BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENOVOCATH RC120

    MDR report key: 14108001 · Received April 13, 2022

    Report

    Report Number
    3011279674-2016-00002
    Event Type
    Injury
    Date Received
    April 13, 2022
    Date of Event
    September 20, 2016
    Report Date
    April 13, 2022
    Manufacturer
    RENOVORX, INC.
    Product Code
    MJN
    PMA / PMN Number
    K141175
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE DID NOT MALFUNCTION AND WAS NOT RETURNED FOR PHYSICAL EXAMINATION. A REVIEW OF THE LOT HISTORY RECORD DID NOT REVEAL ANY ISSUES RELEVANT TO THE REPORTED ADVERSE EVENT. THE TREATING PHYSICIAN HYPOTHESIZED THAT THROMBOSIS OF THE DISTAL SA TERRITORY MAY HAVE BEEN A CAUSE OF THE NECROSIS. A REVIEW OF THE IFU REVEALED THAT INSTRUCTIONS ADEQUATELY ADDRESS ADMINISTRATION OF HEPARIN DURING USE OF THE DEVICE. BASED ON THE AVAILABLE INFORMATION IT WAS NOT POSSIBLE TO ASSIGN A ROOT CAUSE FOR THIS EVENT. THE ROOT CAUSE IS UNKNOWN. THE MANUFACTURER WILL CONTINUE TO TRACK AND TREND FOR THIS EVENT. THIS MDR WAS ORIGINALLY SUBMITTED IN PAPER FORM ON DECEMBER 8, 2016. HOWEVER, THIS MDR IS BEING RESUBMITTED ON APRIL 13, 2022 BECAUSE AN INVESTIGATION DETERMINED THAT THE ORIGINAL PAPER SUBMISSION WAS NOT PROPERLY RECEIVED AND ACCEPTED.

    Description of Event or Problem · 0

    PATIENT UNDERWENT A WHIPPLE PROCEDURE ON 7/26/2016. SHE UNDERWENT 2 TREATMENTS OF THE SUPERIOR MESENTERIC ARTERY WITH INTRAARTERIAL ADMINISTRATION OF GEMCITABINE WITH THE RENOVOCATH ON 9/2/2016 AND 9/19/2016. ON EVENING OF 9/20/2016, PATIENT FELT FATIGUE AND HAD RIGHT LOWER QUADRANT ABDOMINAL PAIN FOLLOWED BY VOMITING. SHE HAD TWO EPISODES OF LARGE EMESIS WITH FREQUENT URINATION. ON 9/22/2016 SHE RECEIVED AN EXPLORATORY LAPAROTOMY. SHE WAS RECORDED TO HAVE HAD A FULL THICKNESS NECROSIS OF THE PANCREATOBILIARY LIMB EXTENDING FROM THE PANCREATICOJEJUNOSTOMY ALL THE WAY TO THE GASTROJEJUNOSTOMY WITH ABRUPT DEMARCATION JUST DISTAL TO THE GASTROJEJUNOSTOMY. IN DISCUSSION WITH THE SURGEON ON 10/26/2016 THROMBOSIS OF THE DISTAL SMA TERRITORY MAY HAVE BEEN A CAUSE OF THE NECROSIS. SUBSEQUENT REVIEW OF THE CATH REPORTS NOTED THAT THE USE OF HEPARIN WAS NOT DOCUMENTED DURING THE 9/19/2016 PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2636673 RENOVOCATH RC120 VASCULAR CLAMP MJN RENOVORX, INC. MMRC120-DB-1111 B2457245A

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Hospitalization GEMCITABINE