BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSESELECT

    MDR report key: 20158985 · Received September 6, 2024

    Report

    Report Number
    3002648230-2024-00410
    Event Type
    Malfunction
    Date Received
    September 6, 2024
    Date of Event
    August 14, 2024
    Report Date
    April 25, 2025
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    QZI
    PMA / PMN Number
    P230017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    PRODUCT EVENT SUMMARY: THE PSCC100 LOOP CATHETER WITH LOT NUMBER 0012350768 WAS RETURNED AND ANALYZED. VISUAL AND X-RAY INSPECTION SHOWED THE CATHETER WAS RECEIVED WITHOUT A GUIDEWIRE AND WITH THE CAPTURE DEVICE REMOVED. THE CATHETER SHAFT WAS OBSERVED BROKEN AT THE HANDLE AREA. THE GUIDEWIRE LUMEN WAS RECEIVED EXTENDED, AND DAMAGED 0.3789 INCHES FROM THE TIP. THE ARRAY PEBAX TUBE AND ELECTRODES WERE INTACT WITH NO APPARENT ISSUES. X-RAY IMAGING SHOWED THE NITINOL ARRAY WIRE WAS INTACT AND PROPERLY ATTACHED TO THE TIP AND TO THE DUAL LUMEN, THE ELECTRODE WIRES INSIDE THE HANDLE WERE ENTANGLED, THE ELECTRODE WIRES INSIDE THE SHAFT WERE BROKEN, AND THE GUIDE WIRE LUMEN WAS KINKED AND DAMAGED INSIDE HANDLE. DATA FROM THE CATHETER IDENTIFICATION CHIP CONFIRMED USAGE ON THE REPORTED EVENT DATE. THE CATHETER WAS REPROGRAMMED, BUT NO FUNCTIONAL TESTING WAS PERFORMED DUE TO THE CONDITION IT WAS RECEIVED IN. THE SLIDE CONTROL FUNCTION WAS STIFF DESPITE SOFTENING OF THE GUIDEWIRE LUMEN. THE STEERING FUNCTION WAS NORMAL, WITH THE DISTAL CATHETER TIP RESPONDING WITH APPROXIMATELY 170°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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PULSED FIELD ABLATION PROCEDURE, THE PULSED FIELD ABLATION CATHETER WAS NOT FLUSHED WHEN REMOVED FROM THE PATIENT. IT WAS SUSPECTED THAT THERE WAS A CLOT AT THE TIP. A KINK AT THE TIP OF THE CATHETER WAS OBSERVED. THE CATHETER WAS REPLACED TO RESOLVE THE ISSUE. THE CASE WAS COMPLETED WITH PULSED FIELD ABLATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1835094 PULSESELECT PERCUTANEOUS CARDIAC ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION WITH QZI MEDTRONIC CRYOCATH LP PSCC100 0012350768

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male