BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB+

    MDR report key: 7313873 · Received March 5, 2018

    Report

    Report Number
    1036844-2018-00082
    Event Type
    Death
    Date Received
    March 5, 2018
    Date of Event
    January 1, 2018
    Report Date
    February 12, 2018
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    FOZ
    PMA / PMN Number
    K071538
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE USER FACILITY WAS CONTACTED (VIA EMAILS AND PHONE) TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT. THE USER FACILITY COULD NOT CONFIRM IF THE DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH. THE USER FACILITY COULD NOT CONFIRM IF THE PATIENT'S PREEXISTING CONDITIONS CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH. NOTE: MEDWATCH (FROM CUSTOMER) DOCUMENTS THE DATE OF PATIENT DEATH AS (B)(6) 2018. TELEFLEX WILL USE (B)(6) 2018 AS DATE OF PATIENT DEATH ON THE MEDWATCH FORM.

    Additional Manufacturer Narrative · 1

    (B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND NO RELEVANT FINDINGS WERE IDENTIFIED. WITHOUT THE DEVICE TO EVALUATE THE COMPLAINT COULD NOT BE CONFIRMED AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 1

    ACCORDING TO THE MEDWATCH ((B)(4)) "DURING A CARDIAC RESUSCITATION, DOCTOR ATTEMPTED CENTRAL LINE PLACEMENT IN THE PATIENT'S RIGHT FEMORAL VEIN. WHEN FEEDING THE GUIDEWIRE, THE WIRE UNRAVELED IN THE PATIENT. SHE HAD DIFFICULTY REMOVING FROM THE PATIENT. PATIENT REQUIRED ANOTHER FEMORAL LINE TO BE PLACED IN LEFT FEMORAL VEIN".

    Description of Event or Problem · 1

    ACCORDING TO THE MEDWATCH ((B)(4)) "DURING A CARDIAC RESUSCITATION, DOCTOR ATTEMPTED CENTRAL LINE PLACEMENT IN THE PATIENT'S RIGHT FEMORAL VEIN. WHEN FEEDING THE GUIDEWIRE, THE WIRE UNRAVELED IN THE PATIENT. SHE HAD DIFFICULTY REMOVING FROM THE PATIENT. PATIENT REQUIRED ANOTHER FEMORAL LINE TO BE PLACED IN LEFT FEMORAL VEIN".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158081 ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB+ CATHETER,INTRAVASCULAR,THERAPE FOZ ARROW INTERNATIONAL INC. 23F17C0534

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death