BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MORPH UNIVERSAL DEFLECTABLE GUIDE CATHETER

    MDR report key: 4532509 · Received February 17, 2015

    Report

    Report Number
    3003610571-2015-00001
    Event Type
    Injury
    Date Received
    February 17, 2015
    Date of Event
    January 28, 2015
    Report Date
    February 11, 2015
    Manufacturer
    BIOCARDIA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K042553
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO BIOCARDIA AND UNDERWENT PHYSICAL EXAMINATION. THERE WAS NO REPORTED DEVICE MALFUNCTION DURING THE PROCEDURE AND THE DEVICE EXAMINATION DID NOT IDENTIFY ANY IRREGULARITIES OR FAILURES THAT WOULD INDICATE THE DEVICE DID NOT MEET SPECIFICATION. THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT OT MANUFACTURE, DESIGN, OR LABELING.

    Description of Event or Problem · 1

    A BIOCARDIA MORPH UNIVERSAL GUIDE CATHETER (00895) WAS INTRODUCED INTO THE LEFT VENTRICLE OF A PATIENT. THE PATIENT EXPERIENCED A VENTRICULAR TACHYCARDIA AND A VENTRICULAR FIBRILLATION. THE EVENT REQUIRED INTERVENTION BY PERFORMING AN EXTERNAL CARDIOVERSION USING AN EXTERNAL DEFIBRILLATOR. THE PATIENT IS KNOWN TO HAVE AN INTERNAL CARDIAC DEFIBRILLATOR; HOWEVER, THE PHYSICIAN DISCONNECTED IT DURING THE PROCEDURE. THE EXTERNAL CARDIOVERSION RESTORED THE PATIENT'S HEAR RHYTHM TO NORMAL AND THE PROCEDURE WAS COMPLETED WITH NO FURTHER ISSUES. NO MEDICATIONS WERE GIVEN TO THE PATIENT DUE TO THIS EVENT. THE PATIENT WAS CONFIRMED TO BE DOING WELL AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113709 MORPH UNIVERSAL DEFLECTABLE GUIDE CATHETER PERCUTANEOUS CATHETER DQY BIOCARDIA, INC. 00895 01210

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention HELICAL INFUSION CATHETER (INVESTIGATION USE)