BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVASIGHT HYBRID SYSTEM

    MDR report key: 20995511 · Received December 20, 2024

    Report

    Report Number
    3012198618-2024-00001
    Event Type
    Malfunction
    Date Received
    December 20, 2024
    Date of Event
    November 21, 2024
    Report Date
    December 20, 2024
    Manufacturer
    CONAVI MEDICAL INC.
    Product Code
    OBJ
    PMA / PMN Number
    K172258
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETURNED DEVICE INVESTIGATION IS CURRENTLY IN PROGRESS. IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED FOLLOWING COMPLETION OF THE DEVICE INVESTIGATION, THE ADDITIONAL RELEVANT INFORMATION WILL BE SUBMITTED IN A FOLLOW-UP REPORT. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT TREND REPORTING SYSTEM. ONGOING ANALYSIS OF TREND INFORMATION WILL BE USED TO IDENTIFY THE NEED FOR ADDITIONAL INVESTIGATIONS. THE SITE WILL BE INFORMED OF THE INVESTIGATION RESULTS.

    Description of Event or Problem · 0

    DURING A CLINICAL CASE WITH DR. (B)(6) ON (B)(6) 2024, THERE WAS AN INCIDENT WHERE THE CATHETER SHEATH DETACHED AND WAS LEFT IN THE BODY. DETAILS BELOW: PATIENT UNDERWENT A CORONARY ANGIOGRAM AND SUBSEQUENT PERCUTANEOUS CORONARY INTERVENTION (PCI) OF THE LEFT ANTERIOR DESCENDING ARTERY (LAD): PROXIMAL-MID LAD LESION (NON-TORTUOUS, NOT OVERLY CALCIFIED OR CHALLENGING). NOVASIGHT HYBRID CATHETER WAS DELIVERED SUCCESSFULLY ACROSS THE LESION AND A HYBRID IVUS (B)(6) IMAGING RUN WAS PERFORMED/USED TO SELECT STENT SIZE. NOVASIGHT HYBRID CATHETER WAS REMOVED FROM BODY/PUT ASIDE PER NORMAL USE (NO ROUGH HANDLING). STENT WAS DEPLOYED IN LESION. NOVASIGHT HYBRID CATHETER WAS DELIVERED SUCCESSFULLY ACROSS THE STENT AND AN IVUS-ONLY IMAGING RUN WAS PERFORMED; FLUSHING WAS PERFORMED PRIOR TO CATHETER INSERTION AND EVERYTHING FELT NORMAL. UPON REMOVAL OF THE IMAGING NOVASIGHT HYBRID CATHETER FROM THE BODY, IT WAS NOTICED BY THE CARDIOVASCULAR TECHNOLOGIST THAT THE CATHETER WAS SHORTER AND A PORTION OF THE CATHETER WAS MISSING. THE DISTAL END OF THE CATHETER (TRANSPARENT REGION) WAS DETACHED FROM THE CATHETER'S SHAFT AND LEFT IN THE BODY AND COULD BE SEEN ON ANGIOGRAPHY. NEXT FLUOROSCOPY WAS DONE WHICH SHOWED TWO RADIOPAQUE MARKERS FROM THE DISTAL PORTION OF THE CATHETER HAD MIGRATED INTO THE DISTAL LAD. THE PHYSICIAN HAD TO USE MULTIPLE WIRES (AND MULTIPLE ATTEMPTS) TO REMOVE THE DISTAL PORTION OF THE CATHETER FROM THE BODY; EVENTUALLY THE FULL PORTION OF THE CATHETER WAS RETRIEVED: THE MAIN OPERATOR DR. (B)(6) CONSULTED WITH ANOTHER INTERVENTIONAL CARDIOLOGIST REGARDING RETRIEVAL OF THE SHEATH. DR. (B)(6) DECIDED TO INTERVENE USING TWO SION BLUE GUIDEWIRES, BY ADVANCING DISTALLY IN THE LAD TO ENTRAP THE CATHETER SHEATH. AT THIS POINT, ADDITIONAL HEPARIN WAS GIVEN TO KEEP ACTIVATED CLOTTING TIME (ACT) AT THERAPEUTIC LEVELS TO PREVENT THROMBOSIS. THIS TECHNIQUE WAS PERFORMED USING FLUOROSCOPIC GUIDANCE TO SUCCESSFULLY REMOVE THE SHEATH. THE RETRIEVED PORTION OF THE CATHETER WAS EXAMINED TO ENSURE ALL PARTS WERE REMOVED AND EVERYTHING SEEMED INTACT/TO BE REMOVED. A SECOND NOVASIGHT HYBRID CATHETER WAS OPENED TO MEASURE AND COMPARE THE LENGTH OF THE DETACHED SHEATH. THE DETACHED SHEATH WAS INTACT BUT BECAME BENT AND ENTWINED IN THE RETRIEVAL PROCESS. A BOSTON SCIENTIFIC OPTICROSS CATHETER WAS USED TO EXAMINE THE VESSEL TO ENSURE THERE WAS NO DAMAGE OR DISSECTIONS CAUSED BY THE INCIDENT -- THERE DID NOT SEEM TO BE ANY VESSEL DAMAGE OR DISSECTIONS. SUBSEQUENTLY A BOSTON SCIENTIFIC IMAGING CATHETER WAS USED TO IMAGE THE ENTIRE LAD VESSEL FROM THE DISTAL TO OSTIAL AND INTO THE LM. CAREFUL ASSESSMENT OF INTRAVASCULAR IMAGING (IVUS) BY DRS. (B)(6) REVEALED THE ENTIRE LAD AND LM VESSELS WERE INTACT WITH NO VESSEL OR STENT (MINIMUM STENT AREA WAS 6.3MM SQUARED, WITH GOOD STENT EXPANSION AND APPOSITION) COMPLICATIONS. THERE WAS 0% RESIDUAL STENOSIS POST INTERVENTION. THE VESSEL HAD TIMI 3 (THROMBOLYSIS IN MYOCARDIAL INFARCTION) FLOW. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2392434 NOVASIGHT HYBRID SYSTEM NOVASIGHT HYBRID SYSTEM OBJ CONAVI MEDICAL INC. TA-06-0001 240502

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Unknown Other| R NOVASIGHT HYBRID SYSTEM-CONSOLE (TA-03-0005).| NOVASIGHT HYBRID SYSTEM-PIM (TA-07-0002).