BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGILIS NXT INTRODUCER, UNKNOWN

    MDR report key: 15508370 · Received September 29, 2022

    Report

    Report Number
    3008452825-2022-00620
    Event Type
    Injury
    Date Received
    September 29, 2022
    Report Date
    October 11, 2022
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DYB
    PMA / PMN Number
    K061363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT DEVICE: SWARTZ¿ INTRODUCER.

    Additional Manufacturer Narrative · 0

    H6 CODE CORRECTED TO 4114.

    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 PSEUDOANEURYSM WAS LIKELY CAUSED BY A LOW LYING ACCESS POINT.

    Description of Event or Problem · 0

    RELATED MANUFACTURING REF:  3005334138-2022-00533. THE FOLLOWING WAS PUBLISHED IN THE JOURNAL OF INTERVENTIONAL CARDIAC ELECTROPHYSIOLOGY IN AN ARTICLE TITLED "HIGH-DENSITY ELECTROANATOMIC MAPPING WITH GRID CATHETER IN PEDIATRICS AND CONGENITAL HEART DISEASE : RECEIVED: 15 APRIL 2021, RECEIVED: 15 APRIL 2021 / ACCEPTED: 29 AUGUST 2022; HTTPS://DOI.ORG/10.1007/S10840-022-01364-0; JOHANNES C. VON ALVENSLEBEN, MD. A RETROSPECTIVE REVIEW OF ALL PEDIATRIC PATIENTS AND THOSE WITH CHD (REGARDLESS OF AGE) WAS CONDUCTED AT CHILDREN¿S HOSPITAL COLORADO AND UNIVERSITY OF COLORADO UNDERGOING ELECTROPHYSIOLOGIC STUDY IN WHICH THE ADVISOR¿ HD GRID MAPPING CATHETER WAS UTILIZED. AT TOTAL OF 65 PROCEDURES WERE CARRIED OUT IN 60 PATIENTS (31 WERE FEMALE (47.6%), MEDIAN AGE 17 YEARS (15¿24.1), HEIGHT 166.5 CM (± 10.7), WEIGHT 68.1 KG (± 20.5)) WITH A TOTAL OF 88 ARRHYTHMIA SUBSTRATES MAPPED INCLUDING AFL/ IART (N = 33), FAT (N = 20), ISOLATED PVCS (N = 10), ACCESSORY PATHWAYS (N = 9), AVNRT (N = 7), RIGHT VENTRICULAR SUBSTRATE MAPPING (N = 7), AND VT (N = 2). FORTYONE PROCEDURES (63%) WERE IN PEDIATRIC PATIENTS, WITH THE SMALLEST PATIENT BEING AN 8-YEAR-OLD, 25.7 KG MALE. PATIENTS HAD CONGENITAL HEART DISEASE IN 30 PROCEDURES (46.1%) WITH MODERATE COMPLEXITY DISEASE IN 10 (33.3%) AND GREAT COMPLEXITY IN 17 (56.6%). FIFTEEN PROCEDURES INCLUDED LEFTSIDED SUBSTRATES. ONE PATIENT DEVELOPED A PSEUDOANEURYSM OF THE LEFT SUPERFICIAL FEMORAL ARTERY. A 9 FRENCH SHORT SHEATH HAD BEEN USED FOR ACCESS AND ONLY DIRECT PRESSURE WAS USED FOR HEMOSTASIS. ASPIRIN (81 MG ONCE DAILY) HAD BEEN PRESCRIBED FOR POST-ABLATION PROPHYLAXIS BUT THE BASELINE PLATELET COUNT WAS NORMAL. THE PATIENT PRESENTED 3 DAYS FOLLOWING HER PROCEDURE WITH PAIN AND SWELLING AT THE ACCESS SITE AND A PRESSURE DRESSING WAS USED FOR COMPRESSION OF THE AFFECTED VESSEL. A FOLLOW-UP ULTRASOUND DEMONSTRATED THROMBOSIS OF THE PSEUDOANEURYSM AND UNOBSTRUCTED FLOW THROUGH THE FEMORAL ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1952432 AGILIS NXT INTRODUCER, UNKNOWN INTRODUCER, CATHETER DYB ST. JUDE MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Female Other