BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACHIEVE ADVANCE MAPPING CATHETER

    MDR report key: 24496609 · Received March 3, 2026

    Report

    Report Number
    2182208-2026-06111
    Event Type
    Malfunction
    Date Received
    March 3, 2026
    Date of Event
    December 5, 2025
    Report Date
    May 27, 2026
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DRF
    UDI-DI
    00763000443238
    PMA / PMN Number
    K162892
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT EVENT SUMMARY: THE DATA FILES AND THE 2ACH20 MAPPING CATHETER WITH LOT NUMBER 9872576 WERE RETURNED AND ANALYZED. TWO PICTURES WERE RECEIVED FOR ANALYSIS. THE FIRST IMAGE SHOWED THE TIP/LOOP OF THE MAPPING CATHETER DAMAGED AND TORN. THE SECOND IMAGE SHOWED THE TIP/LOOP OF THE MAPPING CATHETER DAMAGED AND RIBBED. VISUAL INSPECTION OF THE LOOP SEGMENT AREA SHOWED THE LOOP WAS RIBBED NEAR THE ELECTRODES. THE LOOP WAS DETACHED NEAR ELECTRODE 8. VISUAL INSPECTION OF THE ELECTRODE(S) SHOWED THAT ELECTRODE 8 WAS DISPLACED FROM ITS ORIGINAL LOCATION. VISUAL INSPECTION OF SHAFT SEGMENT AREA SHOWED THE SHAFT WAS INTACT WITH NO APPARENT ISSUES. NO KINK OR ANY OTHER DAMAGE WAS OBSERVED ALONG WITH THE SHAFT OF THE MAPPING CATHETER. VISUAL INSPECTION OF THE INTRODUCER SHOWED THE INTRODUCER WAS INTACT WITH NO APPARENT ISSUES. NO DAMAGE OR ANY OTHER ISSUE WAS OBSERVED ALONG WITH THE INTRODUCER. VISUAL INSPECTION OF THE LEMO CONNECTOR SHOWED THE LEMO CONNECTOR WAS INTACT WITH NO APPARENT ISSUES. NO DAMAGE OR ANY OTHER ISSUE WAS OBSERVED ALONG WITH THE LEMO CONNECTOR. IN CONCLUSION, THE REPORTED ISSUE (MAPPING CATHETER WAS GETTING STUCK AT THE TIP OF THE BALLOON CATHETER) WAS C ONFIRMED THROUGH ANALYSIS. THE CATHETER FAILED THE RETURNED PRODUCT INSPECTION DUE TO A RIBBED MATERIAL ON THE PEBAX TUBING, A BROKEN/DETACHED LOOP (PEBAX TUBING) AND A DISPLACED ELECTRODE THE LOOP OF THE PEBAX TUBING. 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, THE MAPPING CATHETER WAS GETTING STUCK AT THE TIP OF THE BALLOON CATHETER. IT WAS ALSO REPORTED THAT AN ERROR MESSAGE WAS RECEIVED STATING THAT THE SYSTEM DETECTED BLOOD IN THE CATHETER INDICATING THERE WAS BLOOD DETECTED AT THE PATIENT BOARD (CATHETER SHAFT IMPEDANCE WIRE BLOOD DETECTION). DESPITE 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
    40762 ACHIEVE ADVANCE MAPPING CATHETER CATHETER, ELECTRODE RECORDING, OR PROBE, ELECT DRF MEDTRONIC, INC. 2ACH20 9872576 00763000443238

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female 2ACH20 MAPPING CATHETER