BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSESELECT

    MDR report key: 23189652 · Received October 1, 2025

    Report

    Report Number
    3002648230-2025-00943
    Event Type
    Malfunction
    Date Received
    October 1, 2025
    Date of Event
    September 5, 2025
    Report Date
    November 3, 2025
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    QZI
    PMA / PMN Number
    P230017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT EVENT SUMMARY: THE PSCC100 PULSE SELECT CATHETER WITH LOT NUMBER 0012722908 WAS RETURNED AND ANALYZED. DURING EXTERNAL VISUAL INSPECTION OF THE SHAFT AND HANDLE SEGMENTS NO ANOMALIES WERE IDENTIFIED. DURING EXTERNAL VISUAL INSPECTION OF THE ARRAY SEGMENT, ON THE SPIRAL ARRAY SEGMENT, THE SPIRAL ARRAY PEBAX TUBE WAS OBSERVED TO BE KINKED, ON THE SPIRAL ARRAY SEGMENT, A KNOTTED ARRAY WAS OBSERVED, AND ON THE SPIRAL ARRAY SEGMENT, THE GUIDEWIRE LUMEN WAS OBSERVED TO BE KINKED AT 0.5 INCHES FROM THE DISTAL TIP. 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. DEFLECTION TESTING (ROTATING STEERING KNOB CLOCKWISE AND COUNTERCLOCKWISE) WAS PERFORMED, THE DISTAL CATHETER TIP RESPONDED WITH APPROXIMATELY 170° ROTATION IN BOTH DIRECTIONS. NO ANOMALIES WERE OBSERVED. THE SLIDE CONTROL FUNCTION OPERATED AS EXPECTED WITHOUT ANY ISSUES. ELECTRICAL CONTINUITY TEST DID NOT REVEAL ANY ANOMALIES. IN CONCLUSION, THE CATHETER FAILED THE RETURNED PRODUCT INSPECTION DUE TO A KNOTTED SPIRAL ARRAY, KINKED PEBAX TUBING, AND A KINKED 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.

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID: 990045 (LOT: 8831920); PRODUCT TYPE: 0193-GUIDEWIRE PRODUCT EVENT SUMMARY: THE DATA FILES WERE RECEIVED CONTAINING AN IMAGE. THE RETURNED IMAGE FROM THE FIELD SHOWED PULSE FIELD ABLATION CATHETER SPIRAL ARRAY FULLY DEPLOYED WITH A GUIDE WIRE LUMEN KINKED AND TWISTED AND FORMING A KNOT PROXIMAL TO THE TIP. 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, THE CATHETER COULD NOT BE MOVED WHILE BEING POSITIONED IN THE LEFT INFERIOR VEIN. THE CATHETER APPEARED STUCK AND COULD NOT BE RETRACTED INTO THE SHEATH. THE GUIDEWIRE COULD BE RETRACTED INTO THE CATHETER BUT COULD NOT BE EXPOSED BACK OVER THE TIP INTO THE VEIN. SIGNIFICANT MANIPULATION OF THE CATHETER AND SHEATH WAS REQUIRED TO SUCCESSFULLY RETRACT ALL COMPONENTS BACK INTO THE SHEATH. THE CASE WAS COMPLETED WITH PULSED FIELD ABLATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. 2025-10-01: IT WAS LATER REPORTED THAT THE CATHETER WAS ENTRAPPED IN THE PATIENT. BY REPEATED MOVEMENT OF THE SHEATH AND CATHETER, THE CATHETER WAS ABLE TO BE RETRACTED INTO THE SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1795400 PULSESELECT PERCUTANEOUS CARDIAC ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION WITH QZI MEDTRONIC CRYOCATH LP PSCC100 0012722908

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other