BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL1¿, 63 CM LENGTH, 8.5F

    MDR report key: 5819045 · Received July 25, 2016

    Report

    Report Number
    3005334138-2016-00041
    Event Type
    Injury
    Date Received
    July 25, 2016
    Date of Event
    June 21, 2016
    Report Date
    June 27, 2016
    Manufacturer
    ST. JUDE MEDICAL (AFD-PLYMOUTH)
    Product Code
    DYB
    PMA / PMN Number
    PK052644
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 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 INCIDENT 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

    RELATED MFR REPORT NUMBERS: 2030404-2016-00031, 2030404-2016-00032, 3005334138-2016-00042, 2030404-2016-00033. FOLLOWING AN AF ABLATION PROCEDURE, A PERICARDIAL EFFUSION WAS NOTED. THE PATIENT BECAME HYPOTENSIVE AND EXPERIENCED RETROSTERNAL BACK PAIN AND AN ECHOCARDIOGRAM REVEALED A TAMPONADE. THE PATIENT RETURNED TO THE CATH LAB AND A PERICARDIOCENTESIS WAS PERFORMED, WHICH STABILIZED THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY SJM DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471869 SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL1¿, 63 CM LENGTH, 8.5F INTRODUCER, CATHETER DYB ST. JUDE MEDICAL (AFD-PLYMOUTH) 407453 5396743

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention SL1 INTRODUCER