BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSESELECT

    MDR report key: 19975973 · Received August 13, 2024

    Report

    Report Number
    3002648230-2024-00363
    Event Type
    Malfunction
    Date Received
    August 13, 2024
    Date of Event
    April 9, 2024
    Report Date
    August 13, 2024
    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

    PRODUCT EVENT SUMMARY: THE PSCC100 PULSED FIELD ABLATION (PFA) CATHETER WITH LOT NUMBER 0012152076 WAS RETURNED AND ANALYZED. VISUAL INSPECTION SHOWED THE CATHETER WAS RECEIVED WITHOUT THE GUIDEWIRE THREADED THROUGH IT. THE GUIDEWIRE LUMEN WAS RECEIVED FULLY RETRACTED, AND WITH A DEFORMED ARRAY LOOP ASSEMBLY. THE ARRAY PEBAX TUBE WAS TWISTED AT THE PROXIMAL ARM. THE PROXIMAL ARM WAS DEFORMED AND BENT BEYOND THE REQUIRED RANGES CAUSING ELECTRODE NUMBER ONE TO OVERLAP WITH ELECTRODE NUMBER NINE. X-RAY AND OPTICAL INSPECTION WERE PERFORMED. X-RAY IMAGING CONFIRMED THE INTEGRITY OF THE NITINOL ARRAY WIRE, PROPERLY ATTACHED AT THE TIP AND THE DUAL LUMEN BUT THE EMBEDDED SEGMENT OF THE WIRE (BALL AND PORTION OF THE PROXIMAL ARM) WAS TILTED. THE NITINOL ARRAY WIRE APPEARED BENT AT THE PROXIMAL ARM. OPTICAL INSPECTION AT HIGH MAGNIFICATION REVEALED A PEBAX TUBING KINK AT THE DISTAL ARM AND TWISTED AT 0.1 INCHES DISTALLY FROM THE DUAL LUMEN DISTAL END. MECHANICAL VERIFICATION OF STEERING AND SLIDE MECHANISMS WAS PERFORMED. INITIAL STIFFNESS IN THE SLIDE CONTROL FUNCTION, ATTRIBUTED LIKELY TO DRIED BLOOD, WAS ENCOUNTERED, YET STILL OPERATIONAL. UPON FULL ADVANCEMENT OF THE SLIDE CONTROL TO EXTEND THE GUIDEWIRE LUMEN, NO KINKING WAS OBSERVED ALONG THE EXTENDED PORTION. THE STEERING FUNCTION WAS NORMAL, WITH THE DISTAL CATHETER TIP RESPONDING WITH THE EXPECTED ROTATION IN BOTH DIRECTIONS. DATA FROM THE CATHETER IDENTIFICATION CHIP CONFIRMED USAGE ON THE REPORTED EVENT DATE. THE CATHETER WAS REPROGRAMMED BEFORE CONNECTION TO THE GENERATOR VIA A TEST CATHETER INTERFACE CABLE, AND THERAPY DELIVERIES WERE SUCCESSFULLY PERFORMED. THE HIPOT AND ELECTRICAL CONTINUITY TEST WAS PERFORMED. HIPOT VERIFICATION OF THE INTEGRITY OF ELECTRODE WIRES INSULATION AND TESTING FOR ELECTRICAL CONTINUITY REVEALED INTACT ELECTRODE WIRES WITHOUT ANY DETACHMENT OR BREAKAGE. IN CONCLUSION, THE REPORTED ISSUE OF A "BENT ARRAY" WAS CONFIRMED THROUGH RETURNED PRODUCT INSPECTION AND THE CATHETER FAILED THE RETURNED PRODUCT INSPECTION DUE TO THE BENT NITINOL WIRE AND A TWISTED AND KINKED PEBAX TUBE. 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 ARRAY OF THE CATHETER BECAME COMPRESSED UPON USE IN THE RIGHT SUPERIOR PULMONARY VEIN (RSPV). THE CATHETER WAS REMOVED FROM THE SHEATH AND THE ARRAY WAS OBSERVED TO BE BENT, COMPRESSING THE LOOP. THE CATHETER WAS SUBSEQUENTLY REPLACED AND THE CASE WAS COMPLETED WITH PULSED FIELD ABLATION. IT WAS THEN REPORTED THAT THE REPLACEMENT CATHETER APPEARED INVERTED UPON FINAL REMOVAL FROM THE PATIENT AND THE WIRE WAS PULLED BACK FARTHER THAN EXPECTED WHEN THE ARRAY WAS BEING RECAPTURED. THE ARRAY BECAME KNOTTED AND WAS DIFFICULT TO REMOVE FROM THE SHEATH. UPON REMOVAL, EXPOSED WIRING WAS VISIBLE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1682635 PULSESELECT PERCUTANEOUS CARDIAC ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION WITH QZI MEDTRONIC CRYOCATH LP PSCC100 0012152076

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male PRODUCT ID:PSCC100 PRODUCT TYPE: ABLATION CATHETER