BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWARZ FAST-CATH TRANSSEPTAL NEEDLE, BRK SERIES, ADULT 18 GA. 98CM

    MDR report key: 4033970 · Received August 4, 2014

    Report

    Report Number
    3005188751-2014-00093
    Event Type
    Injury
    Date Received
    August 4, 2014
    Date of Event
    July 9, 2014
    Report Date
    July 9, 2014
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DRC
    PMA / PMN Number
    K072278
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION CONCLUDED THAT THE BRK NEEDLE HAD BEEN KINKED AND BENT IN MULTIPLE LOCATIONS THROUGHOUT ITS LENGTH. THE AFOREMENTIONED DAMAGE IS CONSISTENT WITH FORCIBLE CONTACT. THE DEVICE MET SPECIFICATIONS PRIOR TO LEAVING SJM MANUFACTURING FACILITIES AS SUPPORTED BY A REVIEW OF THE DEVICE HISTORY RECORD. THE CAUSE OF THE REPORTED PERICARDIAL EFFUSION REMAINS PROCEDURE RELATED. PER THE IFU, CARDIAC PERFORATION IS AN INHERENT RISK WITH THE USE OF THE DEVICE.

    Description of Event or Problem · 1

    RELATED MANUFACTURER REFERENCE 3005188751-2014-00092. DURING AN ATRIAL ABLATION PROCEDURE USING A SWARTZ FAST-CATH INTRODUCER AND A BRK TRANSSEPTAL NEEDLE, A PERICARDIAL EFFUSION OCCURRED. TRANSSEPTAL ACCESS WAS OBTAINED WITH A BRK TRANSSEPTAL NEEDLE AND A SWARTZ FAST-CATH INTRODUCER WITH ENSITE VELOCITY AND MEDIGUIDE TECHNOLOGY USED TO ISOLATE THE LEFT SUPERIOR PULMONARY VEIN (LSPV). THE PATIENT BECAME HYPOTENSIVE AND AN INTRACARDIAC ECHO (ICE) REVEALED A PERICARDIAL EFFUSION. DURING A PERICARDIOCENTESIS, ASYSTOLE OCCURRED BRIEFLY DURING PERICARDIAL ACCESS AND ATRIAL PACING WAS NEEDED. THE PATIENT'S INTRINSIC HEART RATE RETURNED SOON AFTER AND ICE REVEALED THE EFFUSION HAD RESOLVED AND THE PATIENT WAS STABLE. THE PROCEDURE CONTINUED BUT WHILE RECREATING A NEW LEFT ATRIAL MODEL, THE PATIENT BECAME HYPOTENSIVE AGAIN, AND THE EFFUSION RETURNED. ALL CATHETERS WERE REMOVED AND A PERICARDIOCENTESIS WAS PERFORMED AGAIN TO STABILIZE THE PATIENT. THE PATIENT LEFT THE PROCEDURE ROOM IN STABLE CONDITION. THERE WERE NO PERFORMANCE ISSUES WITH ANY SJM DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455442 SWARZ FAST-CATH TRANSSEPTAL NEEDLE, BRK SERIES, ADULT 18 GA. 98CM TRANSSEPTAL NEEDLE DRC ST. JUDE MEDICAL 407206 4439560

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention SWARTZ FAST-CATH SR0 INTRODUCER (406853)| VIEWFLEX XTRA ICE CATHETER (D087031)| LIVEWIRE ME CATHETER (D402058)| REFLEXION SPIRAL CATHETER (D402893)| SAFIRE BLU DUO ME CATHETER (A700420)