BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRK XS, TRANSSPETAL NEEDLE, 98CM

    MDR report key: 1980367 · Received February 3, 2011

    Report

    Report Number
    3005188751-2011-00011
    Event Type
    Injury
    Date Received
    February 3, 2011
    Date of Event
    January 25, 2011
    Report Date
    January 25, 2011
    Manufacturer
    ST. JUDE MEDICAL, AF DIVISION
    Product Code
    DRC
    PMA / PMN Number
    K072278
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVAL. REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THE DEVICE MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. AS CARDIAC PERFORATION IS A KNOWN RISK ASSOCIATED WITH TRANSSEPTAL PUNCTURE AND CARDIAC ABLATION PROCEDURES, THE CAUSE FOR THE REPORTED PERICARDIAL EFFUSION IS UNK. DATE REPORT SUBMITTED TO FDA BY MANUFACTURER: (B)(6) 2011. DATE THE INITIAL REPORTER PROVIDED THE INFO TO THE MANUFACTURER: (B)(6) 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED A PERICARDIAL EFFUSION WAS NOTED DURING THE PROCEDURE WHEN PERFORMING THE TRANSSEPTAL PUNCTURE. THE EFFUSION WAS RESOLVED WITH A PERICARDIOCENTESIS. THE PT IS REPORTEDLY STABLE. THE PHYSICIAN DOES NOT THINK THE QUALITY OF THE NEEDLE CONTRIBUTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRK XS, TRANSSPETAL NEEDLE, 98CM BRK XS NEEDLE DRC ST. JUDE MEDICAL, AF DIVISION G407211 3241600

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention SORIN QUADRIPOLAR CATHETER ((B)(4), LOT XA312)| BIOSENSE CATHETER ((B)(4) )| AN AGILIS SHEATH ((B)(4), LOT3232576)