BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENOVOCATH

    MDR report key: 13809041 · Received March 18, 2022

    Report

    Report Number
    3011279674-2022-00001
    Event Type
    Malfunction
    Date Received
    March 18, 2022
    Date of Event
    February 22, 2022
    Report Date
    March 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. THE IFU NOTES THE DEVICE IS INTENDED FOR USE IN VESSELS 3.0MM DIAMETER OR GREATER. THE FACT THE DEVICE WAS ATTEMPTED TO BE USED IN AN OCCLUDED VESSEL LIKELY CONTRIBUTED TO THE EVENT. THE IFU ALSO STATES IN THE WARNINGS SECTION: "IF RESISTANCE IS MET DURING MANIPULATION, DETERMINE THE CAUSE OF THE RESISTANCE BEFORE PROCEEDING". THIS WAS NOT ADEQUATELY FOLLOWED WHEN THE CATHETER FELT "STUCK" AND THE PHYSICIAN CONTINUED PULLING, WHICH MAY HAVE CONTRIBUTED TO THE CATHETER BREAKING.

    Additional Manufacturer Narrative · 0

    A TOTAL OF 4 DEVICES WERE RETURNED FOR INVESTIGATION. FOR BOTH DEVICES 1 AND 2, THE EXAMINATION SHOWED EVIDENCE CONSISTENT WITH THE EVENTS ASSOCIATED IN THE CASE WHERE GREAT DIFFICULTY WAS ENCOUNTERED IN CROSSING THE OCCLUSION AND ACCESSING THE TARGET VESSEL LOCATION. NOTHING WAS OBSERVED THAT WOULD BE CONSIDERED INCONSISTENT OR UNEXPECTED WITH THE EVENTS AS DESCRIBED. FOR DEVICE 3 (LOT # Z2458918G), THE DEVICE WAS INTACT BUT APPEARED KINKED IN A FEW PLACES AND A PORTION OF THE SHAFT APPEARED SLIGHTLY DENTED AND COMPRESSED. IT IS UNCLEAR IF THIS HAPPENED DURING THE CASE OR WAS THE RESULT OF THE HANDLING AFTER AND/OR THE DECONTAMINATION PROCESS. THE PROXIMAL BALLOON WAS INFLATED BUT WOULD NOT HOLD PRESSURE AS DESCRIBED IN THE CASE REPORT - NEITHER THE DISTAL OR PROXIMAL BALLOON APPEARED DAMAGED, AND EXAMINATION WAS NOT ABLE TO DETERMINE THE EXACT LOCATION OF THE LEAK. THE DAMAGE SEEN ALONG THE SHAFT AND KINKING ARE CONSISTENT WITH THE SIGNIFICANT MANIPULATION OF THE DEVICE DESCRIBED IN THE CASE WHERE VESSEL TORTUOSITY AND OCCLUSION RESULTED IN DIFFICULTY ACCESSING THE TARGET VESSEL LOCATION. FOR DEVICE 4 (LOT # Z2459353C), THE DEVICE HAD BROKEN INTO 2 PIECES - THE GUIDE WIRE STILL REMAINED IN THE OUTER SHAFT AND HUB, AND THE OUTER SHAFT HAD BEEN STRETCHED AND BROKEN . THE PROXIMAL BALLOON AND MARKER BAND WERE NOT PRESENT. THE INNER SHAFT WAS SIGNIFICANTLY STRETCHED AND THINNED AND WAS BROKEN IN THE MIDDLE PORTION OF THE SHAFT. THE DISTAL BALLOON AND MARKER BAND WAS PRESENT ON THE INNER SHAFT PIECE. THE SHAFT STRETCHING AND DAMAGE/SEPARATION SEEN IS CONSISTENT WITH THE EVENT DESCRIPTION OF EXCESSIVE PUSHING AND PULLING FORCES TO REMOVE THE CATHETER ONCE IT HAD BECOME "STUCK". THE IFU NOTES THE DEVICE IS INTENDED FOR USE IN VESSELS 3.0MM DIAMETER OR GREATER. THE FACT THE DEVICES WERE ATTEMPTED TO BE USED IN AN OCCLUDED VESSEL LIKELY CONTRIBUTED TO THE EVENT. THE IFU ALSO STATES IN THE WARNINGS SECTION: "IF RESISTANCE IS MET DURING MANIPULATION, DETERMINE THE CAUSE OF THE RESISTANCE BEFORE PROCEEDING". THIS WAS NOT ADEQUATELY FOLLOWED WHEN THE CATHETER FELT "STUCK" AND THE PHYSICIAN CONTINUED PULLING, WHICH MAY HAVE CONTRIBUTED TO THE CATHETER BREAKING.

    Description of Event or Problem · 0

    THE RENOVOCATH IS ONLY USED FOR CLINICAL INVESTIGATIONS AT THIS TIME (TIGER-PAC CLINICAL STUDY). INITIAL IMAGING PRIOR TO THE PROCEDURE SHOWED THAT THE PATIENT ANATOMY WAS EXTREMELY CHALLENGING DUE TO ARTERIAL TORTUOSITY AND THE OCCLUSION OF THE TARGET ACCESS VESSEL. THE PHYSICIAN WAS ABLE TO CROSS THE OCCLUSION WITH A 0.014" GUIDE WIRE, BUT WAS UNABLE TO CROSS THE OCCLUSION WITH A 4FR TAPERED TERUMO GUIDE CATHETER. THE PHYSICIAN ATTEMPTED TO PUSH TWO RENOVOCATH DEVICES THROUGH THE OCCLUSION, BUT BOTH CATHETERS "ACCORDIONED" AND WERE UNABLE TO CROSS THE OCCLUSION. BOTH DEVICES WERE REMOVED AND DISCARDED. THE RENOVOCATH IFU STATES THAT THE CATHETER IS INTENDED FOR USE IN ARTERIES 3.0MM DIAMETER OR MORE. A THIRD RENOVOCATH CATHETER WAS UTILIZED AND FORCED THROUGH THE OCCLUSION TO THE TARGET TREATMENT AREA. UPON INFLATION OF THE DISTAL AND PROXIMAL BALLOONS, A LEAK WAS NOTICED SOMEWHERE ALONG THE SHAFT OF THE CATHETER AND THE PROXIMAL BALLOON WOULD NOT STAY INFLATED. THE PHYSICIAN NOTED THAT THE BALLOONS WERE PREPPED AND HELD PRESSURE PER THE IFU PRIOR TO THE PROCEDURE. THE THIRD CATHETER WAS REMOVED FROM THE PATIENT AND A FOURTH RENOVOCATH DEVICE WAS USED TO TRY TO GAIN ACCESS TO THE TARGET VESSEL. THE CATHETER WAS NOT ABLE TO ACCESS THE TREATMENT SITE AND BECAME "STUCK" AFTER SIGNIFICANT FORCE WAS APPLIED. IT IS UNCLEAR AS TO THE CAUSE BEHIND WHY OR HOW THE DEVICE BECAME STUCK. PUSHING AND PULLING FORCES WERE INCREASED TO ATTEMPT TO FREE THE CATHETER AND, AFTER SIGNIFICANT PULLING, IT WAS EVIDENT THE CATHETER HAD BROKEN SOMEWHERE ON THE SHAFT, INSIDE THE GUIDING CATHETER. THE ENTIRE GUIDING CATHETER AND ENTIRE RENOVOCATH CATHETER WERE REMOVED (THE RENOVOCATH WAS NOT IN THE TARGET VESSEL). NOTHING WAS LEFT BEHIND IN THE PATIENT. THE PHYSICIAN COMMENTED THAT HE DID NOT FEEL THE CATHETER WAS DEFECTIVE OR MALFUNCTIONED, BUT THAT THE EXCESSIVE PUSHING AND PULLING FORCE HAD RESULTED IN THE CATHETER BREAKING. NO ADDITIONAL CATHETERS WERE USED AND THE PATIENT WAS SENT HOME WITHOUT RECEIVING CHEMOTHERAPY TREATMENT. NO INJURY TO THE PATIENT RESULTED AND NO FURTHER INTERVENTION WAS REQUIRED. THE PATIENT RETURNED THE FOLLOWING DAY AND WAS SUCCESSFULLY TREATED AFTER THE TARGET OCCLUDED VESSEL WAS FIRST ADEQUATELY OPENED WITH BALLOON ANGIOPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1017511 RENOVOCATH OCCLUSION BALLOON CATHETER MJN RENOVORX, INC. MMRC120-DB-1111

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male