BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NRG TRANSSEPTAL NEEDLE

    MDR report key: 7724549 · Received July 26, 2018

    Report

    Report Number
    9710452-2018-00031
    Event Type
    Injury
    Date Received
    July 26, 2018
    Report Date
    July 26, 2018
    Manufacturer
    BAYLIS MEDICAL COMPANY INC.
    Product Code
    DXF
    PMA / PMN Number
    K073326
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED PATIENT COMPLICATION IS AN INHERENT RISK TO THIS TYPE OF PROCEDURE. THERE IS NO EVIDENCE TO SUGGEST THE BAYLIS MEDICAL DEVICES CAUSED OR CONTRIBUTED TO THE REPORTED COMPLICATIONS. HOWEVER, AS THE BAYLIS DEVICES WERE AMONG THE SEVERAL DEVICES USED IN THE PROCEDURES, BAYLIS MEDICAL HAS DECIDED TO SUBMIT THIS REPORT.

    Description of Event or Problem · 1

    DURING A PERIODIC REVIEW OF PUBLISHED LITERATURE BY THE MANUFACTURER, BAYLIS MEDICAL DEVICES WERE IDENTIFIED AMONG SEVERAL OTHER MANUFACTURERS' DEVICES AS HAVING BEEN USED IN PROCEDURES WITH REPORTED COMPLICATIONS. THERE IS NO EVIDENCE TO SUGGEST THE BAYLIS MEDICAL DEVICES CAUSED OR CONTRIBUTED TO THE REPORTED COMPLICATIONS. HOWEVER, AS THE BAYLIS DEVICES WERE AMONG THE SEVERAL DEVICES USED IN THE PROCEDURES, BAYLIS MEDICAL HAS DECIDED TO SUBMIT THIS REPORT. ARTICLE REFERENCE: ARKLES J, ZADO E, SUPPLE G, ET AL. FEASIBILITY OF TRANSSEPTAL ACCESS IN PATIENTS WITH PREVIOUSLY SCARRED OR REPAIRED INTERATRIAL SEPTUM. JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY (2015); 26(9): 963-968. AS PER THE ARTICLE, "OUR STANDARD EQUIPMENT UNTIL 2006 CONSISTED OF 2 MULLINS SHEATHS (MEDTRONIC, INC., (B)(4), USA) THAT WERE SERIALLY DEPLOYED IN THE (B)(4) WITH STANDARD BROKENBROUGH (BRK) NEEDLES; THE ABLATION AND CIRCULAR MAPPING CATHETER WERE ADVANCED IN THE (B)(4) THROUGH THESE SHEATHS. BEGINNING IN 2007, WE SWITCHED TO THE AGILIS NXT DEFLECTABLE SHEATH AND SL-1 SHEATH (BOTH ST. JUDE MEDICAL INC., (B)(4), USA) WITH ACCOMPANYING BRK OR BRK-1 NEEDLES. THE AGILIS SHEATH WAS TYPICALLY DEPLOYED WITH THE 1ST TSP AND THE SL-1 SHEATH WAS DEPLOYED DURING THE 2ND TSP. IN THE EVENT THAT TSP WAS UNSUCCESSFUL DESPITE USING CAUTERY WITH THE CONVENTIONAL NEEDLE, THE LATTER WAS EXCHANGED FOR ONE OF THE ALTERNATIVE NEEDLE PLATFORMS INCLUDING THE SAFESEPT TRANSSEPTAL GUIDEWIRE (PRESSURE PRODUCTS, (B)(4), USA) OR THE NRG TRANSSEPTAL NEEDLE (BAYLIS, (B)(4), USA)... A 1% (N = 6) RATE OF COMPLICATIONS IN THIS GROUP, ALL OF WHICH WERE PERICARDIAL EFFUSIONS. THREE OF THESE PERICARDIAL EFFUSIONS REQUIRED PERICARDIOCENTESIS AND 3 WERE MANAGED CONSERVATIVELY; NONE REQUIRED CARDIAC SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563674 NRG TRANSSEPTAL NEEDLE RF TRANSSEPTAL NEEDLE DXF BAYLIS MEDICAL COMPANY INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention