BEUDAMED
    FDA Adverse Event Death Summary report: N

    LAUNCHER UNK GUIDE CATHETER

    MDR report key: 21995755 · Received May 9, 2025

    Report

    Report Number
    1220452-2025-00007
    Event Type
    Death
    Date Received
    May 9, 2025
    Date of Event
    October 31, 2024
    Report Date
    June 24, 2025
    Manufacturer
    MEDTRONIC, INC
    Product Code
    DQY
    PMA / PMN Number
    K132673
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CASE STUDY: "THREE FATAL CONSEQUENCES OF ONE GUIDING CATHETER MANEUVER DURING PRIMARY PERCUTANEOUS ANGIOPLASTY IN ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION." YEAR: 2024 AUTHOR: JAN ROCZNIAK, STANISLAW BARTUS, MICHAL CHYRCHEL REF: DOI: 10.20452/PAMW.16881. B 2.3: DATE OF PUBLICATION. 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

    ADDITIONAL INFORMATION: ANNEX D CODE. CORRECTION: ANNEX F CODE. JOURNAL: POLISH ARCHIVES OF INTERNAL MEDICINE ISSUE: 12 PMID: 39498945. 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

    A CASE STUDY WAS SUBMITTED FOR REVIEW TITLED "THREE FATAL CONSEQUENCES OF ONE GUIDING CATHETER MANEUVER DURING PRIMARY PERCUTANEOUS ANGIOPLASTY IN ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION." IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO AN EMERGENCY DEPARTMENT DUE TO SEVERE CHEST PAIN. CORONARY ANGIOGRAPHY WAS PERFORMED, WHICH SHOWED NO SIGNIFICANT LESIONS IN THE LEFT CORONARY ARTERY AND A SUBTOTAL (95%) STENOSIS IN THE MIDDLE SEGMENT OF THE RIGHT CORONARY ARTERY (RCA) WITH (TIMI) 3 FLOW. DUE TO A TORTUOUS COURSE OF THE RCA, A MEDTRONIC 6F AMPLATZ AL 1.0 GUIDING CATHETER WAS USED TO PROVIDE SUFFICIENT SUPPORT. AFTER DELIVERING THE CATHETER TO THE RCA, INITIAL CONTRAST ADMINISTRATION EXPOSED A SEVERE, EXTENSIVE DISSECTION AND TOTAL OCCLUSION OF THE RCA WITH TIMI 0 FLOW. ATTEMPTS WERE MADE TO USE NON-MEDTRONIC GUIDEWIRES TO PASS THE DISSECTION, BUT IT COULD NOT BE PASSED. THE PATIENT DEVELOPED CARDIOGENIC SHOCK CAUSED BY THE AORTIC DISSECTION AS WELL AS CARDIAC TAMPONADE CONFIRMED ON ANGIOGRAPHY. PERICARDIOCENTESIS AND DRAINAGE OF 100 ML OF BLOOD RESTORED HEMODYNAMIC STABILITY. PERCUTANEOUS CORONARY INTERVENTION WAS STOPPED, AND THE PATIENT WAS TRANSFERRED TO AN INTENSIVE CARE UNIT. PATIENT'S CONDITION GRADUALLY WORSENED DESPITE VASOPRESSOR INFUSION. DUE TO HEMODYNAMIC INSTABILITY, A TRANSFER TO A CARDIAC SURGERY CENTER WAS IMPOSSIBLE, AND THE PATIENT WAS DISQUALIFIED AFTER A CONSULTATION. SUBSEQUENT ECHOCARDIOGRAPHY SHOWED SEVERELY HYPOKINETIC RIGHT VENTRICLE AND NO SIGNIFICANT TAMPONADE. AFTER SEVERAL HOURS, CARDIAC ARREST OCCURRED AS A CONSEQUENCE OF PULSELESS ELECTRICAL ACTIVITY, FOLLOWED BY ASYSTOLE, WHICH LED TO THE PATIENT¿S DEATH DESPITE RESUSCITATION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1021157 LAUNCHER UNK GUIDE CATHETER CATHETER, PERCUTANEOUS DQY MEDTRONIC, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Death| R