BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW PI PICC 1-LUMEN: 4FR X 40CM W/ 130CM SS

    MDR report key: 12633109 · Received October 14, 2021

    Report

    Report Number
    9680794-2021-00562
    Event Type
    Malfunction
    Date Received
    October 14, 2021
    Date of Event
    August 4, 2021
    Report Date
    October 14, 2021
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    LJS
    PMA / PMN Number
    K073451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER PROVIDED ONE IMAGE SHOWING A DEFECTIVE PEEL-AWAY SHEATH/DILATOR ASSEMBLY FOR ANALYSIS. VISUAL ANALYSIS REVEALED THAT THE SHEATH BODY WAS SPLIT ALONG THE SCORE LINES. ADDITIONALLY, THE DISTAL TIP APPEARED TO BE SLIGHTLY DAMAGED. THE CUSTOMER ALSO RETURNED ONE, OPENED PICC KIT FOR ANALYSIS. SIGNS-OF-USE IN THE FORM OF BIOLOGICAL MATERIAL WAS OBSERVED INSIDE THE DILATOR EXTRUSION AS WELL AS THE SHEATH EXTRUSION. THIS CONTRADICTS THE CUSTOMER REPORT THAT THE DEFECT WAS OBSERVED BEFORE USED. UPON FOLLOWING-UP WITH THE CUSTOMER ON THIS DISCREPANCY, THEY CONFIRMED THAT THE SAMPLE WAS IN FACT USED ON THE PATIENT. VISUAL ANALYSIS REVEALED THAT THE SHEATH WAS DEFECTIVE. IT WAS OBSERVED THAT A SMALL PORTION OF THE SHEATH EXTRUSION WAS SPLIT. MICROSCOPIC EXAMINATION REVEALED THAT THESE SPLITS OCCURRED ALONG THE SCORE LINES. MICROSCOPIC EXAMINATION REVEALED THAT THE SHEATH TIP WAS ALSO DEFECTIVE. THE SPLITS IN THE SHEATH BODY MEASURED 10MM FROM THE DISTAL TIP. THE TOTAL LENGTH OF THE SPLITS ON BOTH SEAMS OF THE EXTRUSION MEASURED APPROXIMATELY 5MM-10MM. THE SHEATH LENGTH FROM THE TABS TO THE DISTAL TIP MEASURED 4 1/16" WHICH IS WITHIN THE SPECIFICATION LIMITS OF 3 15/16"-4 1/16" PER THE CATHETER PEEL-AWAY GRAPHIC. THE PEEL-AWAY OUTER DIAMETER MEASURED .0758" WHICH IS WITHIN THE SPECIFICATION LIMITS OF .0710"-.0810" PER THE CATHETER PEEL-AWAY EXTRUSION GRAPHIC 3. THE PEEL-AWAY INNER DIAMETER AT THE PROXIMAL END MEASURED .062" WHICH IS WITHIN THE SPECIFICATION LIMITS OF .061"-.066" PER THE CATHETER PEEL-AWAY EXTRUSION GRAPHIC. THE PEEL-AWAY SHEATH TABS WERE SEPARATED AND THE SHEATH WAS SPLIT ALONG THE SCORE LINE. THE SHEATH APPEARED TO SPLIT COMPLETELY DOWN THE EXTRUSION AS EXPECTED WITH LITTLE TO NO DIFFICULTY. PERFORMED PER IFU STATEMENT "GRASP TABS OF PEEL-AWAY SHEATH AND PULL APART, AWAY FROM CATHETER, UNTIL SHEATH SPLITS DOWN ENTIRE LENGTH". R & D WAS CONTACTED AS PART OF THIS COMPLAINT INVESTIGATION. THEY CONFIRMED THAT UNDUE FORCE APPLIED DURING INSERTION LIKELY CAUSED OR CONTRIBUTED TO THE DAMAGE ON THE SEAM LINE AND THE DISTAL TIP. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH NO RELEVANT FINDINGS. THE IFU PROVIDED WITH THE KIT INFORMS THE USER, "THREAD TAPERED TIP OF PEEL-AWAY SHEATH/DILATOR ASSEMBLY OVER GUIDEWIRE. GRASPING NEAR SKIN ADVANCE ASSEMBLY WITH SLIGHT TWISTING MOTION TO A DEPTH SUFFICIENT TO ENTER VESSEL. DILATOR MAY BE PARTIALLY WITHDRAWN TO FURTHER FACILITATE ADVANCEMENT OF SHEATH INTO THE VESSEL. A SLIGHT TWISTING MOTION OF THE PEEL-AWAY MIGHT HELP SHEATH ADVANCEMENT". THE REPORT OF A DAMAGED PEEL-AWAY WAS CONFIRMED THROUGH COMPLAINT INVESTIGATION. VISUAL ANALYSIS REVEALED THAT THE PEEL-AWAY BODY WAS SPLIT ALONG THE SCORE LINES. THE DISTAL TIP ALSO APPEARED TO BE SLIGHTLY DAMAGED. THE DAMAGE TO THE TIP AND BODY OF THE SHEATH ARE CONSISTENT WITHIN UNDUE FORCE BEING APPLIED DURING AN ATTEMPTED INSERTION. ADDITIONALLY, THE PEEL-AWAY MET ALL RELEVANT DIMENSIONAL AND FUNCTIONAL REQUIREMENTS, AND A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH NO EVIDENCE TO SUGGEST A MANUFACTURING RELATED ISSUE. BASED ON THE CUSTOMER REPORT, THE SAMPLE RECEIVED, AND THE COMMENTS FROM R AND D, IT WAS DETERMINED THAT UNINTENTIONAL USE ERROR LIKELY CAUSED OR CONTRIBUTED TO THIS EVENT. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PEEL-AWAY SHEATH WAS DAMAGED DURING PRODUCT PREPARATION. ON (B)(6) 2021, ADDITIONAL INFORMATION WAS RECEIVED AND THE CUSTOMER CONFIRMED THE ISSUE WAS DETECTED DURING PATIENT USE. NO REPORT OF PATIENT HARM.

    Additional Manufacturer Narrative · 1

    QN# (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PEEL-AWAY SHEATH WAS DAMAGED DURING PRODUCT PREPARATION. ON 14 OCTOBER 2021, ADDITIONAL INFORMATION WAS RECEIVED AND THE CUSTOMER CONFIRMED THE ISSUE WAS DETECTED DURING PATIENT USE. NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1531588 ARROW PI PICC 1-LUMEN: 4FR X 40CM W/ 130CM SS CATHETER, INTRAVASCULAR, THER LJS ARROW INTERNATIONAL INC. 14F20M0084

    Patients

    Seq Age Sex Outcome Treatment
    1