BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW CATH-LAB SHEATH INTRO SET

    MDR report key: 14705755 · Received June 15, 2022

    Report

    Report Number
    9680794-2022-00368
    Event Type
    Malfunction
    Date Received
    June 15, 2022
    Date of Event
    May 24, 2022
    Report Date
    May 25, 2022
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DQY
    PMA / PMN Number
    K862056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: 6FR ASAHI HYPERION (ASAHI INTECC). (B)(4).

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D11: 6FR ASAHI HYPERION (ASAHI INTECC) (B)(4). THE CUSTOMER RETURNED ONE 6FR CATH-LAB SHEATH ASSEMBLY AND THREE, NON-ARROW CATHETERS FOR ANALYSIS. THE DILATOR WAS RETURNED INSERTED THROUGH THE SHEATH. NO DEFINITE SIGNS OF USE WERE OBSERVED. VISUAL ANALYSIS DID NOT REVEAL ANY DEFECTS OR ANOMALIES ON THE RETURNED SHEATH/DILATOR ASSEMBLY. ANALYSIS OF THE NON-ARROW CATHETERS REVEALED KINKING/BENDING TOWARDS THE DISTAL END. IT IS LIKELY THIS BENDING CONTRIBUTED TO THE RESISTANCE ENCOUNTERED BY THE CUSTOMER. THE SHEATH BODY LENGTH FROM THE JUNCTURE HUB TO THE DISTAL TIP MEASURED 9 3/4" WHICH IS WITHIN THE SPECIFICATION LIMITS OF 8 7/8"-9 3/4" PER THE SHEATH/DILATOR ASSEMBLY PRODUCT DRAWING. THE SHEATH BODY OUTER DIAMETER MEASURED .1135" WHICH IS WITHIN THE SPECIFICATION LIMITS OF .1110"-.1150" PER THE SHEATH EXTRUSION PRODUCT DRAWING. THE SHEATH INNER DIAMETER AT THE DISTAL TIP MEASURED .086" WHICH IS WITHIN THE SPECIFICATION LIMITS OF .085"-.087" PER THE SHEATH/DILATOR ASSEMBLY PRODUCT DRAWING. DIMENSIONAL ANALYSIS OF THE RETURNED NON-ARROW CATHETERS CANNOT BE PERFORMED AS THE SPECIFICATION LIMITS ARE NOT KNOWN. THE RETURNED DILATOR WAS ABLE TO BE REMOVED AND REINSERTED THROUGH THE RETURNED SHEATH WITH LITTLE TO NO DIFFICULTY. IT WAS NOTED THAT THE DILATOR HUB WAS ABLE TO SNAP INTO THE SHEATH CAP. PERFORMED PER IFU STATEMENT "ENSURE DILATOR HUB FULLY SNAPS INTO SHEATH CAP". THE DILATOR WAS REMOVED FROM THE SHEATH AND THE RETURNED NON-ARROW CATHETERS WERE INSERTED THROUGH THE SHEATH. MINOR RESISTANCE WAS OBSERVED AT THE SHEATH TIP DUE TO THE KINKING ON THE CATHETERS. THE NON-KINKED PORTIONS WERE ABLE TO PASS COMPLETELY THROUGH THE SHEATH WITH LITTLE TO NO ISSUES. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. THE IFU PROVIDED WITH THE KIT INFORMS THE USER, "INTRODUCE TIP OF DESIRED DEVICE THROUGH HEMOSTASIS VALVE AND ADVANCE THROUGH SHEATH INTO VESSEL TO DESIRED POSITION". THE REPORT OF SHEATH TIGHT OVER NON-ARROW CATHETERS WAS CONFIRMED THROUGH COMPLAINT INVESTIGATION. VISUAL AND DIMENSIONAL ANALYSIS DID NOT REVEAL ANY DEFECTS OR ANOMALIES WITH THE RETURNED ARROW SHEATH; HOWEVER , SIGNS OF KINKING/BENDING WERE OBSERVED ON THE RETURNED NON-ARROW CATHETERS. FUNCTIONAL TESTING REVEALED MINOR INSERTION DIFFICULTIES AT THE SHEATH TIP DUE TO KINKING ON THE NON-ARROW CATHETERS. THIS KINKING LIKELY CONTRIBUTED TO THE INSERTION DIFFICULTY; HOWEVER, AS THESE ARE NON-ARROW CATHETERS, THE DIMENSIONS AND FUNCTIONALITY ARE NOT KNOWN. BASED ON THE SAMPLE RETURNED AND THE REPORT FROM THE CUSTOMER, THE ROOT CAUSE CANNOT BE DETERMINED AS THE FUNCTIONALITY AND GENERAL USE OF THE NON-ARROW CATHETERS ARE NOT KNOWN. IT CANNOT BE DETERMINED IF THE ARROW SHEATH CAUSED THE KINKING/BENDING OR IF THIS WAS A RESULT OF UNDUE FORCE APPLIED BY THE CUSTOMER DURING INSERTION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE USER FELT A RESISTANCE WHEN INSERTING A GUIDING CATHETER INTO THE SHEATH. WHEN THE USER ROTATED AND INSERTED WITH FORCE, THE CATHETER KINKED. THE USER REPLACED THE GUIDING CATHETER WITH ANOTHER ONE, BUT THE SAME ISSUE OCCURRED. THEREFORE, THE SHEATH WAS REMOVED AND REPLACED WITH A NEW ONE TO COMPLETE THE PROCEDURE. ACCORDING TO THE USER, THE VESSEL WAS SEVERLY TORTOUS. NO PATIENT HARM REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE USER FELT A RESISTANCE WHEN INSERTING A GUIDING CATHETER INTO THE SHEATH. WHEN THE USER ROTATED AND INSERTED WITH FORCE, THE CATHETER KINKED. THE USER REPLACED THE GUIDING CATHETER WITH ANOTHER ONE, BUT THE SAME ISSUE OCCURRED. THEREFORE, THE SHEATH WAS REMOVED AND REPLACED WITH A NEW ONE TO COMPLETE THE PROCEDURE. ACCORDING TO THE USER, THE VESSEL WAS SEVERLY TORTOUS. NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1132200 ARROW CATH-LAB SHEATH INTRO SET CATHETER PERCUTANEOUS DQY ARROW INTERNATIONAL LLC 14F19B0341

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown 6FR LAUNCHER CORONARY GUIDE CATHETER (MEDTRONIC).| 6FR LAUNCHER CORONARY GUIDE CATHETER (MEDTRONIC).