BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACHIEVE ADVANCE MAPPING CATHETER

    MDR report key: 18967109 · Received March 25, 2024

    Report

    Report Number
    2182208-2024-01256
    Event Type
    Malfunction
    Date Received
    March 25, 2024
    Date of Event
    March 11, 2024
    Report Date
    April 22, 2024
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DRF
    PMA / PMN Number
    K162892
    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 2ACH20 MAPPING CATHETER WITH LOT NUMBER 8812882 WAS RETURNED AND ANALYZED. VISUAL INSPECTION OF THE SHAFT SEGMENT AREA SHOWED THE SHAFT WAS KINKED APPROXIMATELY 57.6 INCHES FROM THE LEMO CONNECTOR. THE FUNCTIONAL TEST WAS PERFORMED AND THE CONTINUITY AND IMPEDANCE MEASUREMENT BETWEEN THE ELECTRODES AND THE OTHER SIDE OF THE CABLE SHOWED THE ELECTRODE'S CONTINUITY AND IMPEDANCE TO THE CABLE ARE NORMAL. IN CONCLUSION, THE REPORTED KINK ISSUE WAS CONFIRMED AND THE MAPPING CATHETER FAILED THE RETURNED PRODUCT INSPECTION DUE TO A SHAFT KINK. 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 CRYO ABLATION PROCEDURE, AFTER INFLATION WAS PERFORMED AND THE RIGHT SUPERIOR PULMONARY VEIN (RSPV) WAS FROZEN. THE MAPPING CATHETER SHAFT INSIDE THE BALLOON CATHETER WAS SLIGHTLY CURVED UNDER IMAGING. THE CASE WAS COMPLETED WITH CRYO. AFTER THE CASE, THE MAPPING CATHETER WAS REMOVED AND IT WAS CONFIRMED THAT THE MAPPING CATHETER TIP WAS KINKED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4872 ACHIEVE ADVANCE MAPPING CATHETER CATHETER, ELECTRODE RECORDING, OR PROBE, ELECT DRF MEDTRONIC, INC. 2ACH20 8812882

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown