BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATH-LAB SHEATH INTRO SET:

    MDR report key: 6096884 · Received November 11, 2016

    Report

    Report Number
    9680794-2016-00202
    Event Type
    Malfunction
    Date Received
    November 11, 2016
    Date of Event
    October 14, 2016
    Report Date
    October 14, 2016
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DYB
    PMA / PMN Number
    K924607
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    QN#(B)(4). ON 11/10/2016 ADDITIONAL INFORMATION RECEIVED: THE PATIENT HAD ARTERIAL BLEEDING. AS A RESULT, A NEW SAF SHEATH WAS PLACED SUCCESSFULLY. ON 11/14/2016 ADDITIONAL INFORMATION RECEIVED: THERE WAS NO SIGNIFICANT BLOOD LOSS. NO BLOOD TRANSFUSION WAS NECESSARY. THERE WAS NO HARM TO THE PATIENT RELATED TO THE LOSS OF BLOOD. INVESTIGATION: THE SAF SHEATH WAS RETURNED SEPARATED FROM THE SHEATH HUB AT THE PROXIMAL END. THE PROXIMAL END OF THE SHEATH APPEARED TO HAVE HAD UNRAVELED. THE DAMAGE IS CONSISTENT WITH REMOVAL DIFFICULTY. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE LOT NUMBER WITH NO RELEVANT FINDINGS. THE DEVICE PASSED ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. CONCLUSION: THE REPORTED COMPLAINT OF THE SHEATH BEING TORN AT THE VALVE HUB IS CONFIRMED. THE SHEATH BODY WAS FOUND UNRAVELING AT THE POINT OF CONNECTION BETWEEN THE VALVE HUB AND THE SHEATH BODY. THE BODY AND HUB WERE SEPARATED FROM EACH OTHER. THE DAMAGE APPEARS CONSISTENT WITH FORCEFUL REMOVAL.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EVENT OCCURRED IN INTENSIVE CARE. PRIOR TO INSERTION THE DEVICE WAS FLUSHED; DILATOR AND SUPER ARROW FLEX (SAF) SHEATH WAS PLACED OVER THE GUIDE WIRE AND ARTERIAL BLEEDING WAS NOTED. THE SAF IS TORN AT THE VALVE. AS A RESULT A NEW SAF SHEATH WAS PLACED SUCCESSFULLY. THERE WAS NO REPORTED DELAY, DEATH, OR COMPLICATIONS TO THE PATIENT AS A RESULT OF THIS OCCURRENCE." ADDITIONAL INFORMATION WAS RECEIVED ON 10/21/2016: THE ARTERIAL BLEEDING WAS NOTED AT THE SIDEARM OF THE SAF SHEATH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EVENT OCCURRED IN INTENSIVE CARE. PRIOR TO INSERTION THE DEVICE WAS FLUSHED; DILATOR AND SUPER ARROW FLEX (SAF) SHEATH WAS PLACED OVER THE GUIDE WIRE AND ARTERIAL BLEEDING WAS NOTED. THE SAF IS TORN AT THE VALVE. AS A RESULT A NEW SAF SHEATH WAS PLACED SUCCESSFULLY. THERE WAS NO REPORTED DELAY, DEATH, OR COMPLICATIONS TO THE PATIENT AS A RESULT OF THIS OCCURRENCE." ADDITIONAL INFORMATION WAS RECEIVED ON 10/21/2016. THE ARTERIAL BLEEDING WAS NOTED AT THE SIDEARM OF THE SAF SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747548 CATH-LAB SHEATH INTRO SET: INTERVENTIONAL PSI PRODUCTS DYB ARROW INTERNATIONAL INC. 14F15J0131

    Patients

    Seq Age Sex Outcome Treatment
    1