BEUDAMED
    FDA Adverse Event Other Summary report: N

    ZYNERGY ZOLUTION ELECTROPHYSIOLOGY CATHETER

    MDR report key: 328353 · Received April 19, 2001

    Report

    Report Number
    2249423-2001-00001
    Event Type
    Other
    Date Received
    April 19, 2001
    Date of Event
    March 12, 2001
    Report Date
    April 19, 2001
    Manufacturer
    ZYNERGY CARDIOVASCULAR, INC.
    Product Code
    DRF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE ALLEGED DIAGNOSTIC EP CATHETER (Z56004) WAS USED DURING A REGULAR "EP" STUDY. NO PACING/STIMULATION WAS REQUIRED. EKG WAS CLEARLY RECORDED. IN THE MIDDLE OF THE PROCEDURE, SYMPTOMS OF CARDIAC TAMPONADE WERE NOTICED. OTHER DIAGNOSTIC AND ABLATION CATHETERS (MANUFACTURERS UNKNOWN) WERE WITHDRAWN. B-ECHO AND X-RAY CONFIRMED CARDIAC TAMPONADE. EMERGENCY PROCEDURES WERE PERFORMED. TWO HOURS LATER, PATIENT'S CRITICAL SIGNS WERE STABILIZED. WITHDRAWAL OF THE ALLEGED CATHETER THROUGH AN INTRODUCER (MANUFACTURER UNKNOWN) WAS ATTEMPTED WITHOUT SUCCESS. CATHETER WAS THEN WITHDRAWN WITH THE INTRODUCER AT THE SAME TIME. PATIENT EXPERIENCED SYMPTOMS OF CARDIAC TAMPONADE AGAIN. AFTER 150 CC BLOOD WAS EVACUATED FROM THE PERICADIAL CAVITY, PATIENT WAS STABILIZED. THE ALLEGED CATHETER WAS EXAMINED AND FOUND THAT THE TIP ELECTRODE HAD SEPARATED FROM THE CATHETER TUBE BUT STILL ATTACHED TO THE SAFETY CABLE. DOCTOR ALSO MENTIONED THAT THE CATHETER WAS USED BEFORE. THIS IS A REUSE OF THE CATHETER. THE INTRODUCER (MANUFACTURER UNKNOWN) WAS IN THE REUSE SITUATION AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17840 ZYNERGY ZOLUTION ELECTROPHYSIOLOGY CATHETER DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER DRF ZYNERGY CARDIOVASCULAR, INC. Z56004 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention INTRODUCER (MFR UNKNOWN) 2001.| EP ABLATION CATHETER (MFR UNKNOWN) 2001,