BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSSEPTAL NEEDLE, BRK SERIES

    MDR report key: 9948119 · Received April 10, 2020

    Report

    Report Number
    3008452825-2020-00193
    Event Type
    Injury
    Date Received
    April 10, 2020
    Report Date
    April 10, 2020
    Manufacturer
    ST. JUDE MEDICAL, COSTA RICA LTDA
    Product Code
    DRC
    PMA / PMN Number
    K072278
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD WAS NOT REVIEWED AS THE BATCH NUMBER WAS NOT AVAILABLE. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED PERICARDIAL EFFUSION, ST ELEVATION, AND TRANSIENT ISCHEMIC ATTACK COULD NOT BE CONCLUSIVELY DETERMINED. PER THE IFU, CARDIAC PERFORATION IS A KNOWN RISK DURING THE USE OF THIS DEVICE.

    Description of Event or Problem · 1

    THE FOLLOWING WAS PUBLISHED IN PACING AND CLINICAL ELECTROPHYSIOLOGY: PACE IN AN ARTICLE TITLED "OVER-THE-NEEDLE TRANS-SEPTAL ACCESS USING THE CRYOBALLOON DELIVERY SHEATH AND DILATOR IN ATRIAL FIBRILLATION ABLATION" BY E STRÖKER ET AL., 2019; 42: 868-873. DOI: 10.1111/PACE.13709. IN THE SETTING OF SECOND-GENERATION CRYOBALLOON (CB2) ABLATION, LEFT ATRIAL (LA) ACCESS IS GENERALLY ACHIEVED USING A STANDARD SHEATH (SS) THAT IS EXCHANGED FOR THE 15FR CRYOBALLOON DELIVERY SHEATH (CBS) AND DILATOR OVER A LONG WIRE (CBS OVER-THE-WIRE TECHNIQUE, CBS-W). THE OBJECTIVE WAS TO EVALUATE THE DIRECT USE OF THE CBS TO GAIN LA ACCESS, BY ADVANCING THE LATTER OVER THE TRANS-SEPTAL NEEDLE (CBS OVER-THE-NEEDLE TECHNIQUE, CBS-N), UNDER TRANSESOPHAGEAL ECHOCARDIOGRAPHIC (TEE) GUIDANCE. THIS STUDY SHOWED THAT THE CBS-N TECHNIQUE IS FEASIBLE AND SAFE UNDER ECHOCARDIOGRAPHIC GUIDANCE. WITHOUT SHEATH EXCHANGE, IT SIMPLIFIES THE CB2 PROCEDURE, IS LESS COSTLY, TIME SPARING, AND MIGHT REDUCE THE RISK OF AIR EMBOLISM. BETWEEN 2015-2017, A TOTAL OF 505 CONSECUTIVE PATIENTS WHO UNDERWENT THE CBS-N APPROACH WERE EVALUATED FOR FEASIBILITY. LA ACCESS WITH THE CBS-N APPROACH COULD BE ACHIEVED IN ALL PATIENTS, WITHOUT MODIFICATION OF THE TECHNIQUE OR USE OF ADDITIONAL EQUIPMENT. CIRCUMFERENTIAL PERICARDIAL EFFUSION WAS SEEN IN 3 PATIENTS ON THE TTE POST-PROCEDURE, CATEGORIZED AS MILD (<10 MM) IN TWO PATIENTS AND MODERATE (10-20 MM) IN ONE PATIENT, TRANSIENT ST ELEVATION OCCURRED IN 5 PATIENTS, AND TRANSIENT ISCHEMIC ATTACK OCCURRED IN 3 PATIENTS WITH NO ANOMALIES OBSERVED ON THE CT SCAN NOT REQUIRING INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411651 TRANSSEPTAL NEEDLE, BRK SERIES TRANSSEPTAL NEEDLE DRC ST. JUDE MEDICAL, COSTA RICA LTDA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention