BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATH-LAB SHEATH INTRO SET

    MDR report key: 4120898 · Received July 28, 2014

    Report

    Report Number
    9680794-2014-00129
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 11, 2014
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DYB
    PMA / PMN Number
    K924607
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EVENT OCCURRED DURING INSERTION WHILE IN THE INTERVENTIONAL RADIOLOGY (IR) DEPARTMENT. THE IR MD STATED THAT IT WAS OBSERVED WHEN INSERTING THE DILATOR INTO THE COILED SHEATH, THE PORT OF THE DILATOR, POSITIONING PROXIMAL OF THE DILATOR WAS BROKEN. ASA RESULT, THE DEVICE WAS NOT USED. A NEW KIT WAS OPENED AND INSERTED WITHOUT ISSUE. THE PROCEDURE WENT ON AS PLANNED SUCCESSFULLY. THE MD STATED THERE WAS NO REPORT OF PATIENT DEATH, COMPLICATIONS, INJURY OR MEDICAL/SURGICAL INTERVENTION REQUIRED. THERE WAS NO DELAY OR INTERRUPTION IN THERAPY NOTED. THE PATIENT OUTCOME WAS NO HARM TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2014 STATED THAT THERE WAS AN APPROXIMATE FIVE-MINUTE DELAY IN THERAPY DURING REPLACEMENT OF THE KIT WITH NO CAUSE HARM TO THE PATIENT NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439796 CATH-LAB SHEATH INTRO SET INTERVENTIONAL PSI PRODUCTS DYB ARROW INTERNATIONAL INC. CF1095413

    Patients

    Seq Age Sex Outcome Treatment
    1