BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGILIS¿ NXT STEERABLE INTRODUCER DUAL-REACH¿ 61 CM SHEATH, SMALL CURL DUAL-REACH

    MDR report key: 7053991 · Received November 22, 2017

    Report

    Report Number
    2182269-2017-00143
    Event Type
    Injury
    Date Received
    November 22, 2017
    Report Date
    November 22, 2017
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    DYB
    PMA / PMN Number
    K061363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSES OF THE REPORTED PHRENIC NERVE PALSY AND PULMONARY VEIN STENOSIS COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    THE FOLLOWING ARTICLE TITLED, "USEFULNESS OF THE STEERABLE SHEATH FOR ATRIAL FIBRILLATION ABLATION" WAS PRESENTED ON AT THE (B)(6). "ONE HUNDRED FOUR PATIENTS WITH AF (84 CASES PAROXYSMAL, 20 CASES PERSISTENT AF) UNDERWENT LEFT ATRIAL ABL FROM MARCH 2015 TO DECEMBER 2016. THE ABLATION CATHETER WAS HANDLED WITH THE STEERABLE SHEATH (AGILLIS NXT, ST JUDE MEDICAL) AND CIRCUMFERENTIAL MAPPING CATHETER WAS PLACED WITH FIXED CURVE SHEATH. MAPPING AND ABL WERE PERFORMED UNDER GUIDANCE OF 3D MAPPING SYSTEM. THERE WAS A TENDENCY OF CORRELATION BETWEEN THE STUDY NUMBER AND TOTAL PROCEDURE TIME, PV ISOLATION TIME, TOTAL FLUOROSCOPIC EXPOSURE DOES, AND MAPPING TIME (P=0.0028). THERE WERE NO COMPLICATIONS SUCH AS CARDIAC TAMPONADE OR STROKE. 1 PATIENT HAD PHRENIC NERVE PALSY AND 2 PATIENTS HAD SEVERE PULMONARY VEIN STENOSIS. AF FREE RATE AT CHRONIC PHASE (8.6±5.1 MONTH AFTER ABLATION) WAS 84.7%. PV ISOLATION TIME WAS REDUCED WITH STEERABLE SHEATH CATHETER NAVIGATION TECHNIQUE, MAPPING TIME OR ADDITIONAL ABLATION TIME WERE ALSO REDUCED BY THE ABLATION NUMBER. SO ONE OF THE REASON OF REDUCING TOTAL PROCEDURE TIME WAS GETTING SKILLED OPERATORS AND STAFF OF THE LABORATORY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831140 AGILIS¿ NXT STEERABLE INTRODUCER DUAL-REACH¿ 61 CM SHEATH, SMALL CURL DUAL-REACH CATHETER, INTRODUCER DYB ST. JUDE MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other