BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACHIEVE MAPPING CATHETER - 20 MM

    MDR report key: 19249120 · Received May 6, 2024

    Report

    Report Number
    9617601-2024-00076
    Event Type
    Malfunction
    Date Received
    May 6, 2024
    Date of Event
    April 29, 2024
    Report Date
    May 31, 2024
    Manufacturer
    MEDTRONIC MEXICO S. DE R.L. DE CV
    Product Code
    DRF
    PMA / PMN Number
    K102588
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 DATA FILES, THREE IMAGE FILES, AND THE 990063-020 MAPPING CATHETER WITH LOT NUMBER 228122733 WERE RETURNED AND ANALYZED. ONE PATIENT FILE WAS RECEIVED AND WAS RECORDED ON THE REPORTED DATE OF THE EVENT. THE PATIENT FILE SHOWED EIGHT APPLICATIONS WERE PERFORMED USING A 2AF283 BALLOON CATHETER WITH LOT NUMBER 25289. THE PATIENT FILE DID NOT SHOW ANY SYSTEM NOTICES ON THE REPORTED DATE OF THE EVENT. THE FIRST IMAGE FILE SHOWED TWO MAPPING CATHETER PACKAGING BOXES. THE FIRST WAS IDENTIFIED AS A 990063-020 MAPPING CATHETER WITH LOT NUMBER 227943442. THE SECOND WAS IDENTIFIED AS A 990063-020 MAPPING CATHETER WITH LOT NUMBER 228122733. THE SECOND IMAGE SHOWED MAPPING CATHETER PROXIMAL SHAFT KINKED. THIRD IMAGE SHOWED A BROKEN MAPPING CATHETER SHAFT AT THE KINK LOCATION. THE REPORTED ISSUE OF A MAPPING CATHETER KINK WAS OBSERVED IN THE IMAGE FILES. VISUAL INSPECTION OF THE SHAFT SEGMENT AREA SHOWED THAT THE SHAFT WAS BROKEN APPROXIMATELY 1.24 INCHES FROM THE LEMO CONNECTOR. INSPECTION ALSO IDENTIFIED BROKEN WIRE AT THE BROKEN SHAFT AREA. VISUAL INSPECTION OF THE INTRODUCER SHOWED THE INTRODUCER WAS BROKEN AT THE PROXIMAL END. THE FUNCTIONAL TEST WAS PERFORMED USING A MULTIMETER AND THE MAPPING CATHETER WAS CONNECTED TO THE TEST CABLE. THE CONTINUITY AND IMPEDANCE MEASUREMENT BETWEEN ELECTRODES AND THE OTHER SIDE OF THE CABLE SHOWED THE ELECTROCARDIOGRAM (ECG) ELECTRODE EIGHT TO PIN EIGHT WAS AN OPEN CIRCUIT. THE REST OF THE CHANNELS WERE NORMAL. DISSECTION OF LEMO CONNECTOR ASSEMBLY REVEALED THAT WIRE EIGHT WAS MOVED FROM SOLDERING INSIDE THE LEMO CONNECTOR. IN CONCLUSION, THE REPORTED ISSUES OF A BROKEN AND KINKED MAPPING CATHETER SHAFT WERE CONFIRMED THROUGH ANALYSIS OF DATA AND RETURNED PRODUCT. THE MAPPING CATHETER FAILED THE RETURNED PRODUCT INSPECTION DUE TO AN OBSERVED BROKEN SHAFT AND A DETACHED ELECTRODE WIRE OBSERVED AT THE WELD. 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. 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, THE MAPPING CATHETER WAS OBSERVED TO BE KINKED WHEN REMOVED FROM THE PATIENT. WHEN PLACING THE MAPPING CATHETER BACK INTO THE BALLOON CATHETER, THE MAPPING CATHETER WAS OBSERVED TO BE BROKEN AND NO LONGER USABLE. THE MAPPING CATHETER WAS REPLACED WHICH RESOLVED THE ISSUES. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522230 ACHIEVE MAPPING CATHETER - 20 MM CATHETER, ELECTRODE RECORDING, OR PROBE, ELECT DRF MEDTRONIC MEXICO S. DE R.L. DE CV 990063-020 228122733

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female