BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEEL-AWAY INTRODUCER KIT 6F, .038, 14 CM SHEATH

    MDR report key: 3951749 · Received July 2, 2014

    Report

    Report Number
    3005188751-2014-00079
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    ST. JUDE MEDICAL INC (AF-MINNESOTA)
    Product Code
    DTB
    PMA / PMN Number
    K894431
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. PER THE IFU, PNEUMOTHORAX IS A KNOWN INHERENT RISK DURING USE OF THIS DEVICE.

    Description of Event or Problem · 1

    DURING A PACEMAKER IMPLANT USING A PEEL-AWAY INTRODUCER, THE PATIENT DEVELOPED A PNEUMOTHORAX. FOLLOWING THE SUBCLAVIAN VENOUS PUNCTURE WITH A PEEL-AWAY INTRODUCER KIT, THE PATIENT BECAME HYPOTENSIVE AND HYPOXIC. A PNEUMOTHORAX WAS DIAGNOSED, CHEST TUBES WERE INSERTED, AND THE PATIENT WAS TRANSFERRED TO ICU. THE PROCEDURE WAS TERMINATED. THE PHYSICIAN BELIEVES THE PNEUMOTHORAX OCCURRED DURING THE SUBCLAVIAN PUNCTURE. THE PATIENT REMAINED STABLE AND A PACEMAKER IMPLANT PROCEDURE WILL BE SCHEDULED SOON. THERE WERE NO ALLEGED PERFORMANCE ISSUES WITH ANY SJM DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386224 PEEL-AWAY INTRODUCER KIT 6F, .038, 14 CM SHEATH WIRE, GUIDE, CATHETER DTB ST. JUDE MEDICAL INC (AF-MINNESOTA) 405104

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention