BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCTIC FRONT ADVANCE PRO¿ CARDIAC CRYOABLATION CATHETER

    MDR report key: 19752755 · Received July 16, 2024

    Report

    Report Number
    2649622-2024-18761
    Event Type
    Malfunction
    Date Received
    July 16, 2024
    Date of Event
    May 9, 2024
    Report Date
    July 16, 2024
    Manufacturer
    MPRI
    Product Code
    OAE
    UDI-DI
    00763000707781
    PMA / PMN Number
    P100010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT EVENT SUMMARY: THE AFAPRO28 BALLOON CATHETER WITH LOT NUMBER 17697 WAS RETURNED AND ANALYZED. DURING EXTERNAL VISUAL INSPECTION OF THE BALLOON, SHAFT, AND HANDLE SEGMENTS, IT WAS OBSERVED THAT THE BALLOON WAS BENT. THE CATHETER SMART CHIP DATA WAS DOWNLOADED AND REVIEWED. DATA INDICATED THE CATHETER WAS USED FOR 23 APPLICATIONS ON THE REPORTED EVENT DATE. THE CATHETER WAS RECOGNIZED AND PASSED THE ELECTRICAL INTEGRITY VERIFICATIONS AND PERFORMANCE TEST. THE CATHETER COMPLETED THE INFLATION, ABLATION, AND THAWING PHASES WITH NO CONSOLE SYSTEM NOTICES GENERATED. NO PERFORMANCE ISSUES WERE IDENTIFIED. ALL THE PRESSURE AND FLOW VALUES WERE IN RANGE AND THE TEMPERATURE CURVE HAD NO OSCILLATION OR OVERSHOOT. DURING INFLATION, A GUIDE WIRE LUMEN KINK WAS OBSERVED INSIDE OF THE BALLOON SEGMENT AND THE PUSH BUTTON WAS STUCK. PRESSURE TESTING AND INSPECTION OF SUB-COMPONENTS OF THE BALLOON, HANDLE, AND SHAFT SEGMENTS WAS PERFORMED. DURING INSPECTION OF THE SHAFT SEGMENT, A GUIDE WIRE LUMEN KINK/TWIST WAS OBSERVED 1.158 INCHES PROXIMAL TO THE CATHETER TIP. PRESSURE TESTING DID NOT IDENTIFY ANY LEAKAGE FROM THE KINK. DURING INSPECTION OF THE HANDLE SEGMENT, THE BELLOW STUCK/WAS GLUED ON THE HYPO-TUBE PUSH BUTTON. IN CONCLUSION, THE BALLOON CATHETER FAILED THE RETURNED PRODUCT INSPECTION DUE TO THE BELL OW BEING STUCK/GLUED ON THE HYPO-TUBE PUSH BUTTON AND A KINK/TWIST OBSERVED ON THE GUIDE WIRE LUMEN. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THERE WAS DIFFICULTY WITH THE BALLOON CATHETER PUSH BUTTON AND THE BALLOON WOULD INFLATE AT AN ANGLE THAT WAS NOT ALIGNED WITH THE MAPPING CATHETER. THE PROCEDURE PROCEEDED WITHOUT REPLACING ANY DEVICES. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2504130 ARCTIC FRONT ADVANCE PRO¿ CARDIAC CRYOABLATION CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE MPRI AFAPRO28 17697 00763000707781

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown