BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INQUIRY STEERABLE CATH. 6F, 1110-6-25-L

    MDR report key: 3951748 · Received July 2, 2014

    Report

    Report Number
    3008452825-2014-00023
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 16, 2014
    Manufacturer
    ST. JUDE MEDICAL INC (AF-IRVINE)
    Product Code
    DRF
    PMA / PMN Number
    K961924
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 CARDIOGENIC SHOCK COULD NOT BE CONCLUSIVELY DETERMINED. PER THE IFU, VASCULAR PERFORATION IS AN INHERENT RISK OF ANY ELECTRODE PLACEMENT.

    Description of Event or Problem · 1

    RELATED MFR REFERENCE 2030404-2014-00071, 3005188751-2014-00081, 2030404-2014-00073. DURING A SUPRAVENTRICULAR TACHYCARDIA STUDY AND ABLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. A VIEWFLEX XTRA ICE CATHETER WAS PLACED IN THE RIGHT ATRIUM FOR IMAGING PURPOSE AND IN INQUIRY QUADRIPOLAR EP CATHETER WAS PLACED IN THE CORONARY SINUS. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A DILATOR ONLY AND SAFIRE BLU DUO ABLATION CATHETER WAS THEN ADVANCED THROUGH AN AGILIS NXT INTRODUCER INTO THE LEFT ATRIUM. ABLATION WAS PERFORMED WITH THE SAFIRE BLU DUO ABLATION CATHETER IN THE LEFT ATRIUM, THE POSTERIOR SEPTAL REGION IN THE RIGHT ATRIUM, AND THE PROXIMAL PORTION OF THE CORONARY SINUS. THE PATIENT BECAME HYPOTENSIVE AND A PERICARDIAL EFFUSION WAS VISUALIZED VIA THE VIEWFLEX ICE CATHETER. A PERICARDIOCENTESIS WAS PERFORMED, WHICH STABILIZED THE PATIENT. THE PROCEDURE WAS THEN SUCCESSFULLY COMPLETED AND THE PATIENT REMAINED STABLE THROUGHOUT. THERE WERE NO PERFORMANCE ISSUES WITH ANY SJM DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385844 INQUIRY STEERABLE CATH. 6F, 1110-6-25-L DRF ST. JUDE MEDICAL INC (AF-IRVINE) 81104 4442945

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CRD-2| COOL POINT TUBING 85785/H549784| INQUIRY QUADRIPOLAR EP CATHETER 81402/4165866| VIEWFLEX XTRA ICE CATHETER D087031/4487130| AGILIS NXT INTRODUCER 408310/4473776| SAFIRE BLUE DUO ABLATION CATHETER A088107/4430788