BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUSON ACUNAV 8F-90 ULTRASOUND CATHETER

    MDR report key: 7080129 · Received December 4, 2017

    Report

    Report Number
    3009498591-2017-00514
    Event Type
    Injury
    Date Received
    December 4, 2017
    Date of Event
    January 1, 2016
    Report Date
    December 4, 2017
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    OBJ
    PMA / PMN Number
    K071234
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO SIEMENS FOR EVALUATION; THEREFORE, A PHYSICAL INVESTIGATION OF THE DEVICE COULD NOT BE PERFORMED. (B)(4).

    Description of Event or Problem · 1

    SIEMENS MEDICAL SOLUTIONS USA, INC. FOUND AN ARTICLE PUBLISHED ON AUG-SEP 2016/ VOLUME 9/ ISSUE 2IN IN THE JOURNAL OF ATRIAL FIBRILLATION TITLED: "ACHIEVING BIDIRECTIONAL LONG DELAYS IN PULMONARY VEIN ANTRAL LINES PRIOR TO BIDIRECTIONAL BLOCK IN PATIENTS WITH PAROXYSMAL ATRIAL FIBRILLATION (THE BI-BI TECHNIQUE FOR ATRIAL FIBRILLATION ABLATION)." IT WAS REPORTED THAT THE PATIENT WAS ANTICOAGULATED PERI-PROCEDURE WITH COUMADIN WITH TARGET INTERNATIONAL NORMALIZED RATIO (INR) BETWEEN 2 AND 3 SECS BOTH BEFORE THE PROCEDURE AS WELL AS AFTER THE PROCEDURE. VENOUS ACCESS WAS OBTAINED WITH ULTRASOUND GUIDANCE USING 8 FRENCH SHEATH INSERTED INTO THE RIGHT COMMON FEMORAL VEIN. THEN A 9 FRENCH SHEATH WAS INSERTED INTO THE LEFT COMMON FEMORAL VEIN AND 7 FRENCH SHEATH WAS INSERTED INTO THE RIGHT INTERNAL JUGULAR VEIN. IT WAS REPORTED THAT AFTER AN ATRIAL FIBRILLATION ABLATION PROCEDURE WHICH UTILIZED AN ACUNAV CATHETER, THE PATIENT DEVELOPED A MODERATE PERICARDIAL EFFUSION THAT WAS SUCCESSFULLY DRAINED WITH NO HEMODYNAMIC CHANGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857599 ACUSON ACUNAV 8F-90 ULTRASOUND CATHETER ULTRASOUND DEVICE OBJ SIEMENS MEDICAL SOLUTIONS USA, INC. ACUNAV 8F-90 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other ACROSS¿ TRANSSEPTAL ACCESS SYSTEM| COUMADIN| DUODECAPOLAR CATHETERS| ENSITE VELOCITY SYSTEM| THE SAFESEPT¿ TRANSSEPTAL GUIDEWIRE