BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW HEMODIALYSIS SET: 2-L 15 FR X 23 CM RETR

    MDR report key: 15973524 · Received December 13, 2022

    Report

    Report Number
    9680794-2022-00775
    Event Type
    Malfunction
    Date Received
    December 13, 2022
    Date of Event
    November 4, 2022
    Report Date
    November 17, 2022
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    MSD
    UDI-DI
    30801902195136
    PMA / PMN Number
    K141051
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). THE CUSTOMER RETURNED ONE GUIDE WIRE AND ALL FOUR OF THE DILATOR TYPES PROVIDED WITHIN THE KIT (16FR SAFE SHEATH D-PRO, TUNNELER DILATOR, 12FR DILATOR, AND 14FR DILATOR). SIGNS OF USE IN THE FORM OF BIOLOGICAL MATERIAL WAS OBSERVED ON THE SAFE SHEATH D-PRO DILATOR. VISUAL ANALYSIS REVEALED THAT THE GUIDE WIRE WAS SEVERELY KINK BENT IN SEVERAL LOCATIONS. MICROSCOPIC EXAMINATION CONFIRMED THE DAMAGE AND REVEALED THAT THE DISTAL AND PROXIMAL WELDS WERE SECURE AND INTACT. NO DEFECTS OR ANOMALIES WERE OBSERVED WITH ANY OF THE RETURNED DILATORS. THE MAJOR KINKS IN THE GUIDE WIRE MEASURED 271MM, 373MM, 483, 525MM, AND 622MM FROM THE PROXIMAL WELD. THE GUIDE WIRE TOTAL LENGTH MEASURED APPROXIMATELY 100.5CM, WHICH IS WITHIN THE SPECIFICATION LIMITS OF 98.75MM-101.25MM PER THE GUIDE WIRE PRODUCT DRAWING. THE GUIDE WIRE OUTER DIAMETER MEASURED .0370", WHICH IS WITHIN THE SPECIFICATION LIMITS OF .0370"-.0385" PER THE GUIDE WIRE PRODUCT DRAWING. THE 14FR DILATOR OUTER DIAMETER MEASURED .185", WHICH EQUALS THE NOMINAL VALUE OF .185" PER THE DILATOR PRODUCT DRAWING. THE 14FR DILATOR INNER DIAMETER AT THE DISTAL TIP MEASURED .041", WHICH IS WITHIN THE SPECIFICATION LIMITS OF .040"-.042" PER THE DILATOR PRODUCT DRAWING. THE 12FR DILATOR OUTER DIAMETER MEASURED .158", WHICH EQUALS THE NOMINAL VALUE OF .158" PER THE DILATOR PRODUCT DRAWING. THE 12FR DILATOR INNER DIAMETER AT THE DISTAL TIP MEASURED .041", WHICH IS WITHIN THE SPECIFICATION LIMITS OF .040"-.042" PER THE DILATOR PRODUCT DRAWING. THE DILATOR FROM THE SAFE SHEATH D-PRO ASSEMBLY OUTER DIAMETER .212", WHICH IS WITHIN THE SPECIFICATION LIMITS OF .209"-.212" PER THE SAFE SHEATH D-PRO PRODUCT DRAWING. THE DILATOR INNER DIAMETER AT THE DISTAL TIP MEASURED .038", WHICH IS WITHIN THE SPECIFICATION LIMITS OF .038"-.039" PER THE SAFE SHEATH D-PRO PRODUCT DRAWING. THE TUNNELING DILATOR OUTER DIAMETER MEASURED .2745", WHICH IS WITHIN THE SPECIFICATION LIMITS OF .2720"-.2780" PER THE TUNNELING DILATOR PRODUCT DRAWING. THE DILATOR INNER DIAMETER AT THE DISTAL TIP MEASURED .130" , WHICH EQUALS THE NOMINAL VALUE OF .130" PER THE TUNNELING DILATOR PRODUCT DRAWING. THE GUIDE WIRE WAS INSERTED THROUGH THE 14FR, 12FR, AND 16FR SAFE SHEATH D-PRO DILATORS. MINOR RESISTANCE WAS ENCOUNTERED AT THE LOCATIONS OF THE KINKING; HOWEVER, THE GUIDE WIRE WAS ABLE TO PASS THROUGH ALL DILATORS. NO RESISTANCE WAS ENCOUNTERED IN AREAS NOT AFFECTED BY KINKING. PERFORMED PER IFU STATEMENT, "CAREFULLY PLACE 12 FR. TISSUE DILATOR ONTO GUIDEWIRE AND ADVANCE TO APPROPRIATE DEPTH. A TWISTING MOTION MAY ASSIST IN ADVANCING THROUGH TISSUE. REPEAT THIS PROCEDURE USING 14 FR TISSUE DILATOR... THREAD DILATOR/SHEATH ASSEMBLY OVER GUIDEWIRE". THE TUNNELING DILATOR IS NOT MEANT TO PASS OVER THE GUIDE WIRE, BUT INSTEAD THE CATHETER. A MANUAL TUG TEST CONFIRMED THAT THE DISTAL AND PROXIMAL WELDS WERE SECURE AND INTACT. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. THE IFU PROVIDED WITH THE KIT INFORMS THE USER, "DO NOT USE EXCESSIVE FORCE WHEN INTRODUCING GUIDEWIRE OR TISSUE DILATOR AS THIS CAN LEAD TO VESSEL PERFORATION, BLEEDING, OR COMPONENT DAMAGE". THE IFU ALSO STATES, "DO NOT USE EXCESSIVE FORCE WHEN INTRODUCING GUIDEWIRE OR TISSUE DILATOR AS THIS CAN LEAD TO VESSEL PERFORATION, BLEEDING, OR COMPONENT DAMAGE". THE REPORT OF A KINKED GUIDE WIRE WAS CONFIRMED THROUGH COMPLAINT INVESTIGATION OF THE RETURNED SAMPLE. VISUAL ANALYSIS REVEALED THAT THE GUIDE WIRE WAS KINKED IN MULTIPLE LOCATIONS ACROSS THE BODY. FUNCTIONAL EVALUATION OF THE DILATORS REVEALED THAT THE UNKINKED PORTIONS OF THE GUIDE WIRE WERE ABLE TO PASS AS EXPECTED, HOWEVER, SLIGHT RESISTANCE WAS MET WHILE ADVANCING THE KINKED PORTIONS. THE GUIDE WIRE AND THE DILATORS MET ALL RELEVANT DIMENSIONAL REQUIREMENTS, AND A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH NO RELEVANT FINDINGS. BASED ON THE CUSTOMER REPORT AND THE SAMPLE RECEIVED, UNINTENTIONAL USE ERROR LIKELY CAUSED OR CONTRIBUTED TO THIS EVENT. 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 "DURING THE INSERTION OF THE DILATOR, THEY ENCOUNTERED RESISTANCE TO INTRODUCTION. AS THEY PULLED OUT THE ENTIRE DEVICE, THEY NOTICED THAT THE GUIDE-WIRE WAS BENT IN SEVERAL POINT." NO PATIENT HARM WAS REPORTED. A NEW GUIDEWIRE WAS USED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "DURING THE INSERTION OF THE DILATOR, THEY ENCOUNTERED RESISTANCE TO INTRODUCTION. AS THEY PULLED OUT THE ENTIRE DEVICE, THEY NOTICED THAT THE GUIDE-WIRE WAS BENT IN SEVERAL POINT." NO PATIENT HARM WAS REPORTED. A NEW GUIDEWIRE WAS USED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2513441 ARROW HEMODIALYSIS SET: 2-L 15 FR X 23 CM RETR CATHETER, HEMODIALYSIS, IMPLA MSD ARROW INTERNATIONAL LLC IPN920475 13F22F0595 30801902195136

    Patients

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