BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSESELECT

    MDR report key: 21103875 · Received January 8, 2025

    Report

    Report Number
    3002648230-2025-00022
    Event Type
    Malfunction
    Date Received
    January 8, 2025
    Date of Event
    December 19, 2024
    Report Date
    February 14, 2025
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    QZI
    PMA / PMN Number
    P230017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT EVENT SUMMARY: THE PSCC100 CATHETER WITH LOT NUMBER 0012501244 WAS RETURNED AND ANALYZED. THE CATHETER WAS RECEIVED WITHOUT THE GUIDEWIRE. THE ARRAY ASSEMBLY WAS KNOTTED BUT NOT INVERTED. THE GUIDEWIRE LUMEN (GWL) WAS RECEIVED RETRACTED AND KINKED AT 0.12 INCHES PROXIMAL TO THE CATHETER TIP. THE PV-TRACKER TEST GUIDEWIRE WAS INSERTED AND THREADED ALONG THE GUIDEWIRE LUMEN OF THE CATHETER. THE TEST GUIDEWIRE WAS BLOCKED AT THE GWL KINK. THE SLIDE CONTROL FUNCTION WAS STIFF DESPITE SOFTENING OF THE GUIDEWIRE LUMEN USING DISINFECTANT TO DILUTE POTENTIAL DRIED BLOOD. THE SLIDING STROKE WAS LIMITED TO TWO-THIRDS OF THE TOTAL SLIDE. CONTINUITY TEST WAS PERFORMED WITH MULTIMETER FOR THE RETURNED CATHETER. THE ELECTRICAL CONTINUITY TEST REVEALED AN OPEN LOOP BETWEEN ELECTRODE #8 AND CONNECTOR PIN #8. X-RAY IMAGING CONFIRMED THE INTEGRITY OF THE NITINOL ARRAY WIRE WHICH WAS PROPERLY ATTACHED AT THE TIP AND THE DUAL LUMEN. THE DIFFICULTY EXTENDING THE GUIDEWIRE LUMEN WAS CAPTURED THROUGH X-RAY IMAGING AS ENTANGLED WIRES. THE ELECTRODE WIRES APPEARED ENTANGLED WITHIN THE SHAFT AT THE DISTAL END OF THE SHAFT. ELECTRODE WIRES WERE BROKEN WITHIN THE SHAFT AT 2 INCHES DISTALLY FROM THE HANDLE NOSE. THE PEBAX TUBING EXHIBITED A TWISTED CONFIGURATION AT THE DISTAL ARM NEAR ELECTRODE #1 AND RIBBED BETWEEN ELECTRODES #1 AND #2. IN CONCLUSION, THE REPORTED SLIDE KNOB ISSUE, SHEATH COMPATIBILITY ISSUE AND THE INVERTED ARRAY WERE CONFIRMED THROUGH TESTING. THE CATHETER FAILED RETURN INSPECTION DUE TO THE TWISTED PEBAX TUBE, GWL KINK, ELECTRODE WIRES ENTANGLED, ELECTRODE WIRE BROKEN AND THE DISTAL ARM PEBAX TUBE RIBBED. 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.

    Additional Manufacturer Narrative · 0

    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 PULSED FIELD ABLATION PROCEDURE, THE SLIDE CONTROL KNOB WAS UNABLE TO PROGRESS PAST THE HALFWAY POINT WHEN ATTEMPTING TO STORE THE CATHETER IN THE SHEATH FOR MOVEMENT. THE CATHETER WAS FORCIBLY STORED IN THE SHEATH AND REMOVED FROM THE PATIENT. IT WAS THEN OBSERVED THAT THE CATHETER ARRAY WAS INVERTED AND LUMP-SHAPED. THE CATHETER WAS REPLACED WHICH RESOLVED THE ISSUE. 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
    1104320 PULSESELECT PERCUTANEOUS CARDIAC ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION WITH QZI MEDTRONIC CRYOCATH LP PSCC100 0012501244

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown