BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW PSI SET: 9 FR

    MDR report key: 10770885 · Received November 2, 2020

    Report

    Report Number
    9680794-2020-00463
    Event Type
    Malfunction
    Date Received
    November 2, 2020
    Date of Event
    October 12, 2020
    Report Date
    October 29, 2020
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DYB
    PMA / PMN Number
    K780532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). THE CUSTOMER RETURNED ONE SWG, ONE SHEATH EXT ASSEMBLY WITH THE DILATOR, AND ONE LIDSTOCK FOR ANALYSIS. SIGNS-OF-USE IN THE FORM OF DRIED BIOLOGICAL MATERIAL WAS OBSERVED ON THE GUIDE WIRE. AFTER INITIALLY FAILING FUNCTIONAL TESTING, A BLOCKAGE WAS DISCOVERED INSIDE THE DILATOR BODY. THIS BLOCKAGE APPEARED CONSISTENT WITH AN EXTRUSION DEFECT DURING MANUFACTURING, AND SUBSEQUENTLY PREVENTED THE GUIDE WIRE FROM PASSING. VISUAL EXAMINATION REVEALED THAT THE GUIDE WIRE WAS SLIGHTLY KINKED TOWARDS THE PROXIMAL END. THIS KINK CORRESPONDED WITH THE PORTION OF THE GUIDE WIRE THAT WAS LOCATED DIRECTLY ADJACENT TO THE DILATOR TIP WHEN INSERTED UP UNTIL THE BLOCKAGE. IT WAS ALSO OBSERVED THAT THE GUIDE WIRE DISTAL J-BEND WAS SLIGHTLY MISSHAPEN. NO OTHER DEFECTS OR ANOMALIES WERE OBSERVED. THE KINK IN THE GUIDE WIRE MEASURED 102MM FROM THE PROXIMAL END. THE BLOCKAGE IN THE DILATOR MEASURED 100MM FROM THE DISTAL TIP. THE GUIDE WIRE TOTAL LENGTH MEASURED 456MM, WHICH IS WITHIN THE SPECIFICATION LIMITS OF 450MM-458MM PER THE DILATOR GRAPHIC. THE GUIDE WIRE OUTER DIAMETER MEASURED .847MM, WHICH IS WITHIN THE SPECIFICATION LIMITS OF .838MM-.877MM PER THE GUIDE WIRE GRAPHIC. THE DILATOR BODY LENGTH FROM THE HUB TO THE TIP MEASURED 7" , WHICH IS WITHIN THE SPECIFICATION LIMITS OF 6 5/8"-7 1/8" PER THE DILATOR GRAPHIC. THE DILATOR INNER DIAMETER (OTHER THAN THE LOCATION OF THE BLOCKAGE) MEASURED .051", WHICH IS WITHIN THE SPECIFICATION LIMITS OF .051"-.055" PER THE DILATOR EXTRUSION GRAPHIC. THE DILATOR OUTER DIAMETER MEASURED .119", WHICH IS WITHIN THE SPECIFICATION LIMITS OF .117"-.120" PER THE DILATOR EXTRUSION GRAPHIC. AN ATTEMPT TO INSERT THE GUIDE WIRE THROUGH THE DILATOR WAS PERFORMED AND MAJOR RESISTANCE WAS ENCOUNTERED, WHICH PREVENTED THE GUIDE WIRE FROM PASSING. A LONG, PIN GAGE WAS USED TO TRY AND CLEAR ANY POTENTIAL BLOCKAGES. THE BLOCKAGE WAS UNABLE TO BE DISLODGED. MANUFACTURING WAS CONTACTED AS PART OF THIS COMPLAINT INVESTIGATION. THEY INDICATED THAT THIS LIKELY OCCURRED DURING THE EXTRUSION PROCESS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. THE CUSTOMER REPORT OF GUIDE WIRE/DILATOR RESISTANCE, WHICH RESULTED IN A KINK ON THE GUIDE WIRE, WAS CONFIRMED THROUGH COMPLAINT INVESTIGATION. VISUAL AND FUNCTIONAL ANALYSES REVEALED THAT THE DILATOR BODY WAS COMPLETELY OCCLUDED DUE TO A BUILD-UP OF RESIN AND BIOLOGICAL MATERIAL. THE GUIDE WIRE AND THE DILATOR MET ALL RELEVANT DIMENSIONAL REQUIREMENTS, AND A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH NO RELEVANT FINDINGS. BASED ON THE RETURNED SAMPLE AND THE COMMENTS FROM THE MANUFACTURER, THIS EVENT LIKELY OCCURRED DURING THE EXTRUSION PROCESS. A NON-CONFORMANCE REQUEST WAS INITIATED TO FURTHER INVESTIGATE THIS COMPLAINT ISSUE. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "THE SHEATH COULD NOT BE PLACED SINCE THE DILATOR IS NOT CONTINUOUS. THE SWG CANNOT BE ADVANCED INTO THE DILATOR."

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "THE SHEATH COULD NOT BE PLACED SINCE THE DILATOR IS NOT CONTINUOUS. THE SWG CANNOT BE ADVANCED INTO THE DILATOR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1233531 ARROW PSI SET: 9 FR INTRODUCER, CATHETER DYB ARROW INTERNATIONAL INC. IPN033616 14F20A0175

    Patients

    Seq Age Sex Outcome Treatment
    1 NONE REPORTED.| NONE REPORTED.