BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATH-LAB SHEATH INTRO SET:

    MDR report key: 6139591 · Received December 1, 2016

    Report

    Report Number
    9680794-2016-00228
    Event Type
    Injury
    Date Received
    December 1, 2016
    Date of Event
    November 24, 2016
    Report Date
    November 25, 2016
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DYB
    PMA / PMN Number
    K924607
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS DISCARDED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT WAS NOT RETURNED FOR EVALUATION. 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. THE OCCURRENCE RATE IS WITHIN ACCEPTABLE RISK LIMITS. THE REPORTED COMPLAINT OF THE DILATOR HUB SEPARATING FROM THE DILATOR BODY IS NOT ABLE TO BE CONFIRMED. THE PRODUCT WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE COMPLAINT IS UNDETERMINED. OTHER REMARKS:

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EVENT OCCURRED IN THE INTENSIVE CARE UNIT. DURING REMOVAL OF THE DILATOR FROM THE SHEATH THE DILATOR GOT BROKEN NEAR THE HOLDER (SNAP-LOCK FEATURE) AND SLIPPED INTO THE PATIENT'S VESSEL. THE RETAINED PIECE OF THE DILATOR, NEED TO BE SURGICALLY REMOVED FROM THE PATIENT. NO DEVICE IS AVAILABLE FOR INVESTIGATION. ADDITIONAL INFORMATION RECEIVED ON 11-29-16: THE PATIENT OUTCOME IS LISTED AS FINE. THE DILATOR SLIPPED APPROX. 3CM INTO THE VESSEL. THE DEVICE WAS DISCARDED BY THE HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EVENT OCCURRED IN THE INTENSIVE CARE UNIT. DURING REMOVAL OF THE DILATOR FROM THE SHEATH THE DILATOR GOT BROKEN NEAR THE HOLDER (SNAP-LOCK FEATURE) AND SLIPPED INTO THE PATIENT'S VESSEL. THE RETAINED PIECE OF THE DILATOR, NEED TO BE SURGICALLY REMOVED FROM THE PATIENT. NO DEVICE IS AVAILABLE FOR INVESTIGATION. ADDITIONAL INFORMATION RECEIVED ON 11-29-2016: THE PATIENT OUTCOME IS LISTED AS FINE. THE DILATOR SLIPPED APPROX. 3CM INTO THE VESSEL. THE DEVICE WAS DISCARDED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788883 CATH-LAB SHEATH INTRO SET: INTERVENTIONAL PSI PRODUCTS DYB ARROW INTERNATIONAL INC. 14F15M0283

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention