BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRODUCER

    MDR report key: 22055567 · Received May 20, 2025

    Report

    Report Number
    3005334138-2025-00264
    Event Type
    Injury
    Date Received
    May 20, 2025
    Report Date
    May 20, 2025
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE AS THE LOT NUMBER IS UNKNOWN. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENTS REMAIN UNKNOWN. MODEL/LOT NUMBER INFORMATION WAS NOT ABLE TO BE OBTAINED FOR THIS DEVICE. THEREFORE, FULL UDI INFORMATION(D4) AND 510K(G3) ARE NOT AVAILABLE.

    Description of Event or Problem · 0

    THE ABBOTT INCROWD PHYSICIAN SURVEY ON EP INTRODUCERS AND MAPPING CATHETERS ARE CONDUCTED IN ACCORDANCE WITH ABBOTT LABORATORIES STANDARD OPERATING PROCEDURES AND THE FOLLOWING: BACKGROUND: ABBOTT COLLABORATED WITH AN EXTERNAL COMPANY THAT CONDUCTS HEALTH PROFESSIONAL SURVEYS, INCROWD, INC. SPECIFICALLY, SURVEYS WERE CONDUCTED TO ASSESS THE SAFETY AND PERFORMANCE EXPERIENCE OF ABBOTT¿S INTRODUCERS AND MAPPING CATHETERS. ELECTROPHYSIOLOGISTS WHO HAVE EXPERIENCE WITH THE INTRODUCERS OR MAPPING CATHETERS WERE SAMPLED IN (B)(6) 2025. METHODS: PHYSICIANS ANONYMOUSLY ANSWERED QUESTIONS ABOUT WHICH OF ABBOTT¿S INTRODUCERS OR MAPPING CATHETERS THEY USED IN THE PRIOR 30 DAYS. THEN, IN REFERENCE TO THE INTRODUCER OR MAPPING CATHETER THEY USED MOST FREQUENTLY, WITH A TARGET OF 1 SURVEY PER DEVICE PER REGION, RESPONDENTS ANSWERED QUESTIONS ON THAT INTRODUCER¿S OR CATHETER¿S SAFETY AND PERFORMANCE. THE STUDY POPULATION INCLUDED ELECTROPHYSIOLOGISTS OR CARDIAC ELECTROPHYSIOLOGISTS FROM THE UK, GERMANY, ITALY, FRANCE, AND SPAIN WHO REGULARLY USED ONE OR MORE OF THE DEVICES IN SCOPE. THE FOLLOWING COMPLICATIONS OCCURRED WITH THE FAST CATH INTRODUCER: ARTERIOVENOUS FISTULA BLEEDING/ANEMIA VASCULAR ACCESS COMPLICATIONS VASCULAR BLEEDING/LOCAL HEMATOMAS/ECCHYMOSIS VASCULAR DAMAGE (E.G., PERFORATION, DISSECTION, OR OBSTRUCTION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736514 INTRODUCER Introducer, catheter DYB ST. JUDE MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other