BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTSPAN TRASSEPTAL NEEDLE AND STYLET KIT

    MDR report key: 3212746 · Received July 2, 2013

    Report

    Report Number
    2529252-2013-00005
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    May 31, 2013
    Report Date
    June 4, 2013
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC. - MALVERN DIVISION
    Product Code
    DRC
    PMA / PMN Number
    K011727
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SITE INITIALLY PROVIDED THE EVENT INFORMATION TO BIOSENSE WEBSTER, INC. (BWI) ON (B)(4) 2013. BWI NOTIFIED ON (B)(6) 2013. COMPLAINT SAMPLE WAS DISCARDED AT THE USER FACILITY. INFORMATION PROVIDED BY BWI INDICATES THAT THE NEEDLE WAS USED AS INTENDED AND THERE WAS NO MALFUNCTION ON THE PART OF THE TRANSSEPTAL NEEDLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED: "IT WAS REPORTED THAT THE PATIENT SUFFERED A PERICARDIAL EFFUSION DURING AN AFIB ABLATION. A BLOOD PRESSURE DROP WAS NOTICED WHILE ABLATING THE RIGHT-SIDED PULMONARY VEINS AND THE EFFUSION WAS CONFIRMED WITH INTRACARDIAC ECHO. THE ABLATION WAS ABORTED AND A PERICARDIOCENTESIS PERFORMED. THE PATIENT LEFT THE LAB WITH STABLE BLOOD PRESSURE AND WAS TRANSFERRED TO CICU. THE PHYSICIAN BELIEVES THAT THE PERFORATION RESULTING IN EFFUSION OCCURRED DURING THE TRANSSEPTAL PORTION OF THE PROCEDURE. BWI EQUIPMENT USED: C3 SYSTEM SN: (B)(4) STOCKERT SN: (B)(4) COOLFLOW PUMP SN: (B)(4) PREFACE SHEATHS X 2, UNKNOWN CATALOG AND LOT #'S (PACKAGING AND DEVICE DISPOSED OF) LASSO NAV ECO, 2515, UNKNOWN CATALOG AND LOT #'S (PACKAGING AND CATHETER DISPOSED OF) SUPRA CS CATHETER, 110, UNKNOWN CATALOG AND LOT #'S (PACKAGING AND CATHETER DISPOSED OF) THERMOCOOL SF DF WITH CURVE VISUALIZATION, UNKNOWN LOT (PACKAGING AND CATHETER DISPOSED OF) HEARTSPAN TRANSSEPTAL NEEDLE, UNKNOWN CATALOG AND LOT #'S (PACKAGING AND CATHETER DISPOSED OF) SOUNDSTAR CATHETER, UNKNOWN LOT (PACKAGING AND CATHETER DISPOSED OF."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301366 HEARTSPAN TRASSEPTAL NEEDLE AND STYLET KIT TRANSSEPTAL NEEDLE AND STYLET KIT DRC MERIT MEDICAL SYSTEMS, INC. - MALVERN DIVISION FND-020-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SUPRA CS CATHETER, 110, UNK CATALOG AND LOT #'S| (PACKAGING AND DEVICE DISPOSED OF)| (PACKAGING AND DEVICE DISPOSED OF)| PREFACE SHEATHS X 2, UNK CATALOG AND LOT #'S| (PACKAGING AND DEVICE DISPOSED OF)| (PACKAGING AND DEVICE DISPOSED OF)| (PACKAGING AND DEVICE DISPOSED OF)| HEARTSPAN TRANSSEPTAL NEEDLE,UNK CATALOG & LOT #'S| F: THE SITE INITIAILLY PROVIDED THE EVENT I| SOUNDASTAR CATHETER, UNK LOT| BWI EQUIPMENT USED: C3 SYSTEM SN: (B)(4)| STOCKERT SN: (B)(4)| THERMOCOOL SF DF WITH CURVE VISUALIZATION, UNK LOT| (PACKAGING AND DEVICE DISPOSED OF)| COOLFLOW PUMP SN: (B)(4)| LASOO NAV ECO, 2515, UNK CATALOG AND LOT #'S