BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW AGBA PICC NAVICURVE: 2L 5.5FR X 55CM TCG

    MDR report key: 21168959 · Received January 16, 2025

    Report

    Report Number
    9680794-2025-00002
    Event Type
    Malfunction
    Date Received
    January 16, 2025
    Date of Event
    December 27, 2024
    Report Date
    December 30, 2024
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    LJS
    UDI-DI
    10801902208733
    PMA / PMN Number
    K220363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). ONE VPS RHYTHM DLX K-01352-001 STYLET NAVIGATION STYLET: .018" X 30-25/32" LG AND ONE DOUBLE LUMEN COATED CATHETER WERE RETURNED FOR INVESTIGATION. A VISUAL EXAMINATION OF THE STYLET REVEALED THE STYLET WAS SEPARATED APPROXIMATELY 7/8 INCHES FROM THE TIP. THE SEPARATED PIECE OF THE RETURNED STYLET BODY MEASURED APPROXIMATELY 7/8 INCHES. THE REMAINING BODY OF THE STYLET HAD KINKS APPROXIMATELY 1 1/2 INCHES, 5 INCHES, AND 25 INCHES FROM THE STYLET TIP. A COMPARISON TO A KNOWN GOOD DLX STYLET REVEALED THE COMPLETE STYLET WAS RETURNED. A VISUAL EXAMINATION OF THE CATHETER REVEALED THE CATHETER WAS TRIMMED TO 38 CM WITH NO OBVIOUS EXTERNAL DEFECTS OR ANOMALIES. THE STYLET DOES NOT APPEAR TO HAVE BEEN TRIMMED EVEN THOUGH THE CATHETER WAS TRIMMED, THE SEPARATION OCCURRED BELOW THE KINKED AREA, THE KINKED AREA IS THE DESIGNED FLEX AREA OF THE STYLET; THE TUBING AT BOTH SEPARATIONS APPEARS TO HAVE BEEN SUBJECTED TO A FORCE, RESULTING IN THE SEPARATION OF THE STYLET BODY. A DEVICE HISTORY RECORD REVIEW PERFORMED ON THE STYLET DID NOT REVEAL ANY MANUFACTURING RELATED ISSUES. THE REPORTED ISSUE WAS CONFIRMED BY EVALUATION OF THE RETURNED SAMPLE. ALTHOUGH THE COMPLAINT WAS CONFIRMED, A ROOT CAUSE RELATED TO THE MANUFACTURING PROCESS WAS NOT IDENTIFIED. THE PROBABLE CAUSE FOR THIS ISSUE COULD NOT BE DETERMINED. TELEFLEX WILL CONTINUE TO MONITOR AND TREND REPORTS OF THIS NATURE.

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED "UNABLE TO THREAD PICC LINE PAST LENGTH OF INTRODUCER, WHEN PULLED OUT PICC LINE, THE STYLET WAS NOTED TO BE PAST THE CATHETER AND BENT AT A 90-DEGREE ANGLE. SUDDENLY, THE PART OF THE STYLET THAT WAS BENT BROKE OFF OUTSIDE OF THE PATIENT. THE LENGTH OF THE NAVICURVE WAS COMPARED TO AN INTACT NAVICURVE TO ENSURE THERE WAS NO WIRE LEFT BEHIND IN THE PATIENT". THE PATIENT HAD NO HARM OR INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED "UNABLE TO THREAD PICC LINE PAST LENGTH OF INTRODUCER, WHEN PULLED OUT PICC LINE, THE STYLET WAS NOTED TO BE PAST THE CATHETER AND BENT AT A 90-DEGREE ANGLE. SUDDENLY, THE PART OF THE STYLET THAT WAS BENT BROKE OFF OUTSIDE OF THE PATIENT. THE LENGTH OF THE NAVICURVE WAS COMPARED TO AN INTACT NAVICURVE TO ENSURE THERE WAS NO WIRE LEFT BEHIND IN THE PATIENT". THE PATIENT HAD NO HARM OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757921 ARROW AGBA PICC NAVICURVE: 2L 5.5FR X 55CM TCG CATHETER, INTRAVASCULAR, THERA LJS ARROW INTERNATIONAL LLC 33F24E0622 10801902208733

    Patients

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