BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSSEPTAL NEEDLE, BRK 1, 71CM

    MDR report key: 3062923 · Received April 12, 2013

    Report

    Report Number
    3005188751-2013-00057
    Event Type
    Injury
    Date Received
    April 12, 2013
    Date of Event
    March 28, 2013
    Report Date
    March 28, 2013
    Manufacturer
    ST. JUDE MEDICAL, INC. (AF-MINNETONKA)
    Product Code
    DRC
    PMA / PMN Number
    K072278
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. OUR INVESTIGATION WAS LIMITED TO THE REVIEW OF THE DEVICE HISTORY RECORD, WHICH SHOWED THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND INDICATED COMPLETE IN ACCORDANCE WITH SJM SPECIFICATIONS AND PROCEDURES. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED PERICARDIAL EFFUSION COULD NOT BE CONCLUSIVELY DETERMINED. PER THE IFU, CARDIAC PERFORATION IS AN INHERENT RISK OF ANY TRANSSEPTAL PROCEDURE.

    Description of Event or Problem · 1

    RELATED TO MFR REFERENCE 2030404-2013-00031. DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE PERFORMED USING A SAFIRE BLU DUO ABLATION CATHETER AND BRK TRANSSEPTAL NEEDLE, A PERICARDIAL EFFUSION OCCURRED. THE PHYSICIAN PERFORMED TRANSSEPTAL PUNCTURE USING A BRK TRANSSEPTAL NEEDLE AND A RESTERILIZED SL0 INTRODUCER AND ADVANCED A HANSEN SHEATH WITH A SAFIRE BLU DUO ABLATION CATHETER INTO THE LEFT ATRIUM. WHILE THE PHYSICIAN WAS PERFORMING ABLATION AROUND THE PULMONARY VEINS, THE PATIENT BECAME HYPOTENSIVE. INTRACARDIAC ECHOCARDIOGRAPHY REVEALED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED WHICH STABILIZED THE PATIENT. THE EFFUSION RESOLVED AND THE PATIENT WAS TRANSFERRED TO ICU FOR OBSERVATION. THE PHYSICIAN STATED THERE WERE NO PERFORMANCE ISSUES WITH ANY SJM DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157775 TRANSSEPTAL NEEDLE, BRK 1, 71CM TRANSSEPTAL NEEDLE DRC ST. JUDE MEDICAL, INC. (AF-MINNETONKA) 407201 3948350

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SAFIRE BLU ((B)(4))| SL0 INTRODUCER (REPROCESSED)| HANSEN SHEATH ((B)(4))| VIEWFLEX ((B)(4))