BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW CATH-LAB SHEATH INTRO SET

    MDR report key: 17377071 · Received July 24, 2023

    Report

    Report Number
    9680794-2023-00513
    Event Type
    Malfunction
    Date Received
    July 24, 2023
    Date of Event
    May 22, 2023
    Report Date
    June 26, 2023
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DQY
    PMA / PMN Number
    K862056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). THE REPORT OF A KINKED/BENT SHEATH WAS NOT ABLE TO BE CONFIRMED THROUGH COMPLAINT INVESTIGATION OF THE RETURNED SAMPLE. THE CUSTOMER RETURNED ONE, OPENED CATH-LAB SHEATH KIT FOR ANALYSIS. NO DEFINITE SIGNS-OF-USE WERE OBSERVED. VISUAL ANALYSIS DID NOT REVEAL ANY OBVIOUS DEFECTS OR ANOMALIES ON THE RETURNED SHEATH NOR THE DILATOR. ADDITIONALLY, NO DEFECTS OR ANOMALIES WERE OBSERVED WITH THE RETURNED TRAY. THE SHEATH LENGTH FROM THE HUB TO THE DISTAL TIP MEASURED 9 11/16" VIA CALIBRATED RULER, WHICH WAS WITHIN THE SPECIFICATION LIMITS OF 8 7/8" - 9 3/4" PER THE SHEATH PRODUCT DRAWING. THE SHEATH OUTER DIAMETER MEASURED 0.1029" VIA CALIBRATED MICROMETER, WHICH WAS WITHIN THE SPECIFICATION LIMITS OF 0.0990"-0.1030" PER THE SHEATH EXTRUSION PRODUCT DRAWING. FUNCTIONAL INSPECTION WAS PERFORMED ON THE RETURNED DILATOR PER IFU STATEMENT, "ENSURE DILATOR HUB FULLY SNAPS INTO SHEATH CAP". THE RETURNED DILATOR WAS INSERTED INTO THE SHEATH. THE DILATOR WAS ABLE TO PASS COMPLETELY THROUGH THE SHEATH BODY. THE DILATOR HUB WAS ABLE TO SNAP INTO THE SHEAT H CAP WITH LITTLE TO NO ISSUE. THE IFU PROVIDED WITH THE KIT INFORMS THE USER, "DO NOT USE IF PACKAGE IS DAMAGED". A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. BASED ON THE CUSTOMER REPORT AND THE SAMPLE RECEIVED, NO PROBLEM WAS FOUND WITH THE RETURNED DEVICE. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: THE PHYSICIAN FOUND THAT THE SHEATH WAS BENT PRIOR TO USE ON THE PATIENT. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE. ANOTHER KIT WAS OPENED FOR THE PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: THE PHYSICIAN FOUND THAT THE SHEATH WAS BENT PRIOR TO USE ON THE PATIENT. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE. ANOTHER KIT WAS OPENED FOR THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795002 ARROW CATH-LAB SHEATH INTRO SET CATHETER PERCUTANEOUS DQY ARROW INTERNATIONAL LLC 14F22D0021

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown NOT REPORTED.| NOT REPORTED.