BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATH-LAB SHEATH INTRO SET

    MDR report key: 5434525 · Received February 12, 2016

    Report

    Report Number
    9680794-2016-00025
    Event Type
    Malfunction
    Date Received
    February 12, 2016
    Date of Event
    February 11, 2016
    Report Date
    February 11, 2016
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DYB
    PMA / PMN Number
    K924607
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE REPORT THAT THE DILATOR HUB BROKE OFF DURING USE WAS CONFIRMED. ONE SAF SHEATH/DILATOR AND A LIDSTOCK WERE RETURNED. VISUAL EXAMINATION REVEALED THE HUB ON THE PROXIMAL END OF THE DILATOR IS SEPARATED FROM THE BODY. THE BROKEN SURFACES WERE EXAMINED MICROSCOPICALLY. THE WHITISH APPEARANCE AND ROUGH SURFACE ON THE PROXIMAL END OF THE DILATOR BODY INDICATES THAT THE HUB HAD BEEN PROPERLY ATTACHED AND APPEARS. DURING FUNCTIONAL TESTING, THE DILATOR HUB WAS SECURELY "CLICKED INTO" THE HEMOSTATIS VALVE CAP OF THE SAF SHEATH. THE DILATOR GRAPHIC SPECIFIES THE OUTSIDE DIAMETER (OD) OF THE BODY AT .123/.126 INCHES AND THE DIAMETER AT THE NOTCH IN THE HUB AT .149/.151 INCHES. THE OD OF THE DILATOR BODY MEASURED .124" AND THE OD AT THE NOTCH IN THE HUB MEASURED .149". THE OUTSIDE DIAMETER AT THE BOTTOM OF THE HUB MEASURED .152"; THIS DIMENSION IS NOT SPECIFIED ON THE GRAPHIC. THE INSIDE DIAMETER OF THE SHEATH HEMOSTASIS VALVE CAP MEASURE .146" WHICH MEETS THE .144/.147" REQUIREMENT. A DEVICE HISTORY RECORDS REVIEW WAS PERFORMED AND DID NOT SUGGEST ANY MANUFACTURING RELATED ISSUES. THE DILATOR HUB APPEARS TO HAVE BEEN SEPARATED BY EXCESSIVE LATERAL FORCE, THEREFORE OPERATIONAL CONTEXT CAUSED OR CONTRIBUTED TO THIS EVENT. NO FURTHER ACTION WILL BE TAKEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THE SHEATH WAS BEING PLACED INTO THE PATIENT'S GROIN IN THE CATH LAB. DURING INSERTION, THEY WERE PLACING THE SHEATH WHEN THE DILATOR WOULDN'T "CLICK IN" AS SUPPOSED TO AND BROKE OFF WHEN TRYING TO LOCK IT IN PLACE. AS A RESULT, A NEW SHEATH WAS OBTAINED AND USED SUCCESSFULLY. THERE WAS AN ADDITIONAL MINUTE DELAY IN TREATMENT WITH NO PATIENT HARM AND NO PATIENT DEATH OR COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90254 CATH-LAB SHEATH INTRO SET CRITICAL CARE PSI PRODUCTS DYB ARROW INTERNATIONAL INC. 14F15L0016

    Patients

    Seq Age Sex Outcome Treatment
    1