BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACHIEVE MAPPING CATHETER - 20 MM

    MDR report key: 12857187 · Received November 22, 2021

    Report

    Report Number
    9617601-2021-00176
    Event Type
    Malfunction
    Date Received
    November 22, 2021
    Date of Event
    November 6, 2021
    Report Date
    December 22, 2021
    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

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    PRODUCT EVENT SUMMARY: PHOTOS OF A MAPPING CATHETER AND A 990063-020 MAPPING CATHETER WITH LOT NUMBER 221315551 WAS RETURNED AND ANALYZED. THE FIRST RETURNED PHOTO SHOWED THE SHAFT WAS BENT AT THE ATTACHMENT TO THE LEMO CONNECTOR. THE SECOND PHOTO SHOWED THE SHAFT WAS BROKEN AT THAT PLACE. VISUAL INSPECTION OF MAPPING CATHETER SHOWED THE SHAFT WAS BROKEN 0.125 INCH FROM THE LEMO CONNECTOR. NO ELECTROCARDIOGRAM (ECG) SIGNAL WIRES WERE BROKEN INSIDE THE SHAFT. SINCE THE SHAFT WAS BENT, THE SHAFT INTEGRITY WAS ALREADY WEAKEN AND MAY BRAKE OFF DURING THE TRANSPORT. IN CONCLUSION, THE REPORTED MAPPING CATHETER KINK WAS CONFIRMED THOUGH TESTING AND ANALYSIS OF PHOTOS. THE MAPPING CATHETER FAILED THE RETURNED PRODUCT INSPECTION DUE TO THE A KINK ON THE SHAFT. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THAT THE MAPPING CATHETER WAS ATTEMPTED TO BE ADVANCED INTO THE BALLOON CATHETER THROUGH THE Y VALVE. IT WAS OBSERVED THAT THE TIP OF THE MAPPING CATHETER WAS BENT. 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
    1751893 ACHIEVE MAPPING CATHETER - 20 MM CATHETER, ELECTRODE RECORDING, OR PROBE, ELECT DRF MEDTRONIC MEXICO S. DE R.L. DE CV 990063-020 221315551

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male