BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN COOL TIP ELECRTRODE

    MDR report key: 20896312 · Received December 10, 2024

    Report

    Report Number
    1717344-2024-02208
    Event Type
    Injury
    Date Received
    December 10, 2024
    Date of Event
    June 18, 2024
    Report Date
    December 10, 2024
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCTS: UNKNOWN COOL TI - UNKNOWN COOL TIP ELECRTRODE, LOT# UNKNOWN LITERATURE EVENTS: AUTHOR: XUDONG XIE, PHD*; SIYUAN CHEN , MBBS*; YAWEI CUI, MSC; ZHENZHEN ZHOU, BSC; JIANHUA LU, BSC; ZHI DU , PHD; JIE DING, PHD; KAIDI XING, MBBS; YUESHENG ZHANG, MBBS; YIJIANG ZHOU , MD; JUN LI, PHD; XIAOGANG GUO , PHD TITLE: MIDTERM OUTCOMES OF PERCUTANEOUS INTRAMYOCARDIAL SEPTAL RADIOFREQUENCY ABLATION FOR HYPERTROPHIC CARDIOMYOPATHY: A SINGLE-CEN TER, OBSERVATIONAL STUDY, XIAOGANG DR. GUO, J AM HEART ASSOC. 2024 SOURCE: DOI: 10.1161/JAHA.123.034080 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

    ACCORDING TO THE LITERATURE, A RETROSPECTIVE COHORT STUDY INVESTIGATED THE EFFICACY AND SAFETY OF PERCUTANEOUS INTRAMYOCARDIAL SEPTAL RADIOFREQUENCY ABLATION (PIMSRA) FROM ANOTHER INDEPENDENT CENTER FOR THE TREATMENT OF HYPERTROPHIC OBSTRUCTIVE CARDIOMYOPATHY. BETWEEN APRIL 2020 TO JUNE 2023, 76 PATIENTS WERE TREATED WITH PIMSRA USING COOL TIP. THE FOLLOWING PROCEDURAL COMPLICATIONS WERE REPORTED: PERICARDIAL EFFUSION IN 6 PATIENTS. OF THESE PATIENTS, 1 UNDERWENT PERICARDIOCENTESIS FOLLOWED BY SURGERY, 2 UNDERWENT PERICARDIOCENTESIS AND SEPTAL BRANCH BALLOON OCCLUSION, 2 RECEIVED PERICARDIOCENTESIS ONLY, AND ONE WAS TREATED CONSERVATIVELY. AMONG THEM, 1 PATIENT DEVELOPED CARDIAC TAMPONADE IMMEDIATELY AFTER THE INSERTION OF THE NEEDLE AND NEEDED PERICARDIOCENTESIS, AND THUS THE ABLATION WAS NOT CONDUCTED. SHE SUFFERED VENTRICULAR FIBRILLATION REQUIRING RESUSCITATION THE NEXT DAY AND A STROKE LATER DURING HOSPITALIZATION. ACCELERATED IDIOVENTRICULAR RHYTHM OCCURRED IN TWO PATIENTS. ONE PATIENT DEVELOPED SEPTAL BRANCH ANEURYSM AND CORONARY RIGHT VENTRICULAR FISTULA AND WAS TREATED WITH COIL OCCLUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1710642 UNKNOWN COOL TIP ELECRTRODE ELECTROSURGICAL, CUTTING & COAGULATION & ACCES GEI COVIDIEN MFG DC BOULDER UNKNOWN COOL TIP ELECRTRODE

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Hospitalization| R| O