BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSESELECT

    MDR report key: 21948294 · Received May 2, 2025

    Report

    Report Number
    3002648230-2025-00379
    Event Type
    Malfunction
    Date Received
    May 2, 2025
    Date of Event
    February 28, 2025
    Report Date
    May 2, 2025
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    QZI
    UDI-DI
    00763000617554
    PMA / PMN Number
    P230017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT EVENT SUMMARY: THE PSCC100 CATHETER OF LOT NUMBER 0012601264 WAS RETURNED AND ANALYZED. VISUAL INSPECTION WAS CARRIED OUT. NO ANOMALIES WERE IDENTIFIED DURING EXTERNAL VISUAL INSPECTION OF THE ARRAY, SHAFT, AND HANDLE SEGMENTS. CATHETER IDENTIFICATION AND ABLATION TESTING WAS CARRIED OUT. THE PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) CHIP WAS REPROGRAMMED FOR FUNCTIONAL TESTING. THE CATHETER PASSED PERFORMANCE FUNCTIONAL TESTING WITH THE GENERATOR; THERAPY DELIVERIES WERE COMPLETED WITH NO SYSTEM ERRORS GENERATED. NO PERFORMANCE ISSUES WERE IDENTIFIED. CATHETER TO SHEATH COMPATIBILITY TESTING WAS CARRIED OUT. DURING COMPATIBILITY TESTING, THE CATHETER TO THE SHEATH INSERTION FAILED. THE SLIDER COULD NOT ADVANCE FULLY. VERIFICATION OF STEERING MECHANISM. DEFLECTION TESTING (ROTATING STEERING KNOB CLOCKWISE AND COUNTER-CLOCKWISE) WAS PERFORMED, THE DISTAL CATHETER TIP RESPONDED WITH APPROXIMATELY 170° ROTATION IN BOTH DIRECTIONS. NO ANOMALIES WERE OBSERVED. VERIFICATION OF SLIDING MECHANISMS. DESPITE ATTEMPTS TO SOFTEN THE GUIDEWIRE LUMEN WITH DISINFECTANT TO DILUTE POTENTIAL DRIED BLOOD, THE SLIDE CONTROL FUNCTION REMAINED STIFF, LIMITING ITS FULL RANGE OF MOTION. ELECTRICAL CONTINUITY AND HIPOT/LOPOT VERIFICATION WAS CARRIED OUT. ELECTRICAL CONTINUITY TEST DID NOT REVEAL ANY ANOMALIES. HIPOT VERIFICATION FOR THE INTEGRITY OF ELECTRODE WIRES INSULATION REVEALED INTACT ELECTRODE WIRES WITHOUT ANY INSULATION DAMAGE. INSPECT ION (MICROSCOPE/X-RAY IMAGING) AND TESTING WAS PERFORMED TO VERIFY THE INTEGRITY OF THE CATHETER SUB-COMPONENTS. DURING INSPECTION OF THE SHAFT SEGMENT, ENTANGLED ELECTRODE WIRES WERE OBSERVED. IN CONCLUSION, THE CATHETER FAILED THE RETURN PRODUCT INSPECTION DUE TO ENTANGLED ELECTRODE WIRES. 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 CARDIAC ABLATION PROCEDURE USING THE PULSED FIELD ABLATION CATHETER, THERE WERE CATHETER STEERING AND DEFLECTION ISSUES. THE CATHETER EXPERIENCED RESISTANCE WHEN RETRACTING BACK INTO THE SHEATH AFTER THE SECOND PASS OF ABLATION. ADDITIONALLY, THE SLIDER MECHANISM CLICKED WHEN ATTEMPTING TO BRING THE ELECTRODES INTO ITS SPIRAL CONFIGURATION, NECESSITATING A REPLACEMENT OF THE CATHETER MID-PROCEDURE. THE CASE WAS COMPLETED WITH PULSED FIELD ABLATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208023 PULSESELECT PERCUTANEOUS CARDIAC ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION WITH QZI MEDTRONIC CRYOCATH LP PSCC100 0012601264 00763000617554

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female