BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW CATH-LAB SHEATH INTRO SET

    MDR report key: 9172087 · Received October 9, 2019

    Report

    Report Number
    9680794-2019-00391
    Event Type
    Malfunction
    Date Received
    October 9, 2019
    Date of Event
    August 22, 2019
    Report Date
    October 8, 2019
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DQY
    PMA / PMN Number
    K862056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER RETURNED ONE DILATOR AND LIDSTOCK FOR EVALUATION. VISUAL INSPECTION REVEALED A SLIGHT BEND IN THE DILATOR BODY. NO OTHER DEFECTS OR ANOMALIES WERE OBSERVED ON THE RETURNED DEVICE. THE OVERALL LENGTH OF THE DILATOR BODY MEASURED 6.77" WHICH IS WITHIN SPECIFICATION OF 6.75-7.25" PER PRODUCT DRAWING. THE OUTER DIAMETER OF THE DILATOR WAS MEASURED IN THREE DIFFERENT LOCATIONS ALONG THE BODY TO CHECK FOR CONSISTENCY. NEAR THE HUB MEASURED .083", IN THE MIDDLE MEASURED .084" AND BY THE TIP MEASURED .084". THESE ARE WITHIN SPECIFICATION OF .082-.085" PER PRODUCT DRAWING. THE INNER DIAMETER OF THE TIP MEASURED .041" WHICH IS WITHIN SPECIFICATION OF .039-.041" PER PRODUCT DRAWING. AN INVENTORY GUIDE WIRE SIMILAR TO THE SIZE AS PROVIDED WITHIN THIS KIT WAS ABLE TO PASS THROUGH THE RETURNED DILATOR WITH MINIMAL RESISTANCE. THOUGH THE CUSTOMER DESCRIBED THE DEFECT AS FOUND IN USE, A QUERY WAS COMPLETED ON THE FINAL KIT PROVIDED TO RULE OUT ANY PRIOR PACKAGING ISSUES. NO DEFECTS OF DILATOR BODY DEFORMATIONS WERE FOUND IN THE QUERY. A DHR REVIEW WAS COMPLETED WITH NO RELEVANT FINDINGS. THE IFU PROVIDED WITH THIS KIT TELLS THE USER "PERFORM SKIN WHEAL USING DESIRED NEEDLE" BEFORE PLACING THE DILATOR AND TO "ADVANCE ASSEMBLY INTO VESSEL WITH SLIGHT TWISTING MOTION TO DESIRED POSITION". THE CUSTOMER COMPLAINT OF DILATOR DAMAGE IS CONFIRMED THROUGH THIS INVESTIGATION. THERE IS A SLIGHT BEND TO THE DILATOR BODY. HOWEVER, THE RETURNED DEVICE MET ALL RELEVANT DIMENSIONAL SPECIFICATIONS AND A DHR WAS PERFORMED WITH NO RELEVANT FINDINGS. THOUGH THE CUSTOMER DESCRIBED THE DEFECT AS FOUND IN USE, A QUERY WAS COMPLETED ON THE FINAL KIT PROVIDED TO RULE OUT ANY PRIOR PACKAGING ISSUES. NO DEFECTS OF DILATOR BODY DEFORMATIONS WERE FOUND IN THE QUERY. SINCE THE DEFECT OF THE DEVICE WAS FOUND IN USE, THE MOST LIKELY ROOT CAUSE OF THIS DEFECT IS USE ERROR. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR COMPLAINTS OF THIS NATURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "TIP OF DILATOR IS NARROW POINTED AND THAT IS WHY IT IS DIFFICULT FOR INSERTION AT FEMORAL SIGHT OF THE PATIENT".

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRELIMINARY EVALUATION OF THE RETURNED DEVICE INDICATES DILATOR BODY/HUB DAMAGED - FOUND DURING USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "TIP OF DILATOR IS NARROW POINTED AND THAT IS WHY IT IS DIFFICULT FOR INSERTION AT FEMORAL SIGHT OF THE PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    965419 ARROW CATH-LAB SHEATH INTRO SET CATHETER PERCUTANEOUS DQY ARROW INTERNATIONAL INC. 14F18A0603

    Patients

    Seq Age Sex Outcome Treatment
    1