BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVISOR¿ HD GRID MAPPING CATHETER, SENSOR ENABLED¿

    MDR report key: 22177493 · Received June 10, 2025

    Report

    Report Number
    3008452825-2025-00274
    Event Type
    Injury
    Date Received
    June 10, 2025
    Date of Event
    June 6, 2025
    Report Date
    September 5, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    DRF
    UDI-DI
    05415067028198
    PMA / PMN Number
    K202066
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H2, H3, H6. ONE BI-DIRECTIONAL, CURVE D-F, SENSOR ENABLED, ADVISOR HD GRID MAPPING CATHETER WAS RECEIVED FOR EVALUATION. THE CATHETER WAS RETURNED WITHOUT THE PADDLE ATTACHED. IN ADDITION, MULTIPLE IMAGES AND VIDEOS WERE RETURNED SHOWING THE CATHETER WITHIN THE PATIENT DURING THE PROCEDURE AS WELL AS THE ATTEMPTED SNARE REMOVAL. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. INFORMATION FROM THE FIELD INDICATED THAT THE USE OF FORCE WAS ATTEMPTED IN THE REMOVING OF THE CATHETER. THE ADVISOR HD GRID SE CATHETER INSTRUCTIONS FOR USE (IFU) STATES, "DO NOT USE FORCE TO ADVANCE OR WITHDRAW CATHETER WHEN RESISTANCE IS ENCOUNTERED." THE CAUSE OF THE MATERIAL SEPARATION AND REPORTED REMOVAL ISSUE IS CONSISTENT WITH NOT FOLLOWING THE INSTRUCTIONS FOR USE.

    Description of Event or Problem · 0

    DURING A VENTRICULAR TACHYCARDIA (VT) PROCEDURE, THE TIP OF THE CATHETER DETACHED DURING PULL BACK FROM FEMORAL ARTERY. DURING VT ABLATION, 2 FEMORAL VENOUS (7F) AND 1 ARTERIAL PUNCTURE (9F) WERE PERFORMED. CORONARY SINUS (SC) AND RIGHT VENTRICULAR (RV) CATHETERS WERE PLACED AND RV STIMULATION WAS PERFORMED. AFTER VT INDUCTION, SUBSTRATE MAPPING WAS ATTEMPTED. THE MAPPING CATHETER WAS INSERTED INTO ARTERIAL SYSTEM WITH A RETROGRADE APPROACH TO THE LEFT VENTRICLE; THE CATHETER WAS MOVING AND STEERING NORMALLY. IN THE AORTIC ROOT, THE MAPPING CATHETER WAS INSERTED, BUT THE AORTIC VALVE COULD NOT BE PASSED. THE CATHETER WAS THEN PULLED BACK IN ORDER TO ACHIEVE A STRAIGHT CATHETER POSITION IN THE AORTA. A SECOND ATTEMPT TO PASS THE AORTIC VALVE WAS UNSUCCESSFUL. THE CATHETER WAS THEN PULLED BACK INTO THE SHORT VENOUS SHEATH, BUT COULDN¿T BE PULLED OUT WITHOUT RESISTANCE. FLUOROSCOPY OF THE PUNCTURE SITE WAS PERFORMED WHICH SHOWED A BENT SHEATH. WHEN ATTEMPTING TO PULL BACK MAPPING CATHETER OUT OF THE PATIENT, THE CATHETER RIPPED AND THE HD GRID PADDLE AS WELL AS THE TWO SHAFT ELECTRODES REMAINED PARTIALLY IN THE SHEATH AND IN THE ARTERIAL SYSTEM. A MICROSNARE KIT WAS USED IN AN ATTEMPT TO RETRIEVE THE DETACHED PORTION OF THE CATHETER VIA THE EXISTING SHEATH. THIS WAS UNSUCCESSFUL AND THE SHEATH AND SNARE WERE PULLED BACK OUTSIDE THE BODY. HOWEVER, THE CATHETER REMAINED IN THE ARTERIAL SYSTEM WITH THE SHAFT MOST LIKELY IN THE INITIAL PUNCTURE SITE. THE LEFT FEMORAL ARTERY WAS THEN PUNCTURED WITH THE IDEA TO CROSS OVER ARTERIALLY AND THEN RETRIEVE THE HD GRID WITH THE SNARE CATHETER. CROSS OVER ATTEMPT WAS SUCCESSFUL, HOWEVER, THE HD GRID COULDN¿T BE RETRIEVED WITH THE SNARE. SEVERAL UNSUCCESSFUL ATTEMPTS WERE MADE AND IT WAS DECIDED TO RELOCATE THE PATIENT TO ANOTHER HOSPITAL WITH A VASCULAR SURGERY DEPARTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1344050 ADVISOR¿ HD GRID MAPPING CATHETER, SENSOR ENABLED¿ CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF ABBOTT MEDICAL D-AVHD-DF16 10629139 05415067028198

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention