BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW PI PICC NAVICURVE: 1L 4FR X 55CM W BP

    MDR report key: 22715902 · Received August 5, 2025

    Report

    Report Number
    9680794-2025-00658
    Event Type
    Malfunction
    Date Received
    August 5, 2025
    Date of Event
    July 11, 2025
    Report Date
    July 11, 2025
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    LJS
    UDI-DI
    10801902208757
    PMA / PMN Number
    K220363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). ONE VPS RHYTHM DLX K-01352-001 STYLET NAVIGATION STYLET: .018" X 30-25/32" LG WAS RETURNED. A VISUAL EXAMINATION REVEALED THE LAST PART OF THE STYLET IS SHAPED IN A J SHAPE (CURVED) REPORTED. A VISUAL REVEALED THREE KINKS APPROXIMATELY 13/16 TO 1 INCH FROM THE STYLET DISTAL TIP. IT WAS REPORTED "WHEN WE PULLED THE STYLET OUT TO MEASURE AND ASSESS THAT THE NAVICURE TIP WAS INTACT, THEY COULD FEEL AND VISIBLY SEE THAT THERE WERE SHARP BARBS (APPROXIMATELY 5) NEAR THE DISTAL TIP OF THE STYLET." NO EVIDENCE OF "BARBS" ON THE STYLET WERE OBSERVED. NO EVIDENCE OF "BARBS" ON THE STYLET COULD BE FELT WHEN MOVING BARE (NOT GLOVED) FINGERS ALONG THE STYLET BODY EVEN AT THE KINK AREAS. THE CUSTOMER ALSO PROVIDED SEVEN PHOTOS FOR EVALUATION. THE PHOTOS SHOW THE DISTAL TIP OF THE NAVICURVE STYLET BENT AND CURVED , AND A HOLE IN THE CATHETER BODY. AS NOTED IN THE VISUAL EXAMINATION, THREE (3) KINKS WERE OBSERVED APPROXIMATELY 13/16 TO 1 INCH FROM THE STYLET DISTAL TIP. NO EVIDENCE OF "BARBS" ON THE STYLET WERE OBSERVED. IN ADDITION, ONE PHOTO SHOWS THAT THE END OF THE CORE (ECG) WIRE HAS A RADIUS AND DOES NOT END IN A POINT. THE STYLET WAS FUNCTIONALLY TESTED WITH THE STYLET TIP SUBMERGED IN A SALINE SOLUTION AND USING A KNOWN GOOD RHY DLX SYSTEM. DURING THE TESTING, A GOOD CONNECTION WITH THE REMOTE CONTROL WAS ACHIEVED, A GOOD NAVIGATION TRACE WAS ACHIEVED, AND A STEADY INTERNAL ECG SIGNAL WITH NO NOISE OR ARTIFACT WAS DISPLAYED. THE NO CONNECTION ICON AND THE NO IV ICON DISPLAYED AS INTENDED. NO PROBLEM WAS FOUND WITH THE FUNCTIONALITY OF THE RETURNED STYLET. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED , AND NO RELEVANT FINDINGS WERE IDENTIFIED. THE REPORTED ISSUE WAS NOT CONFIRMED DURING EVALUATION OF ONE RETURNED VPS RHYTHM DLX K-01352-001 STYLET NAVIGATION STYLET: .018" X 30-25/32" LG. A VISUAL EXAMINATION REVEALED THE LAST PART OF THE STYLET IS SHAPED IN A "J" AS REPORTED. A VISUAL EXAMINATION REVEALED THREE KINKS APPROXIMATELY 13/16 TO 1 INCH FROM THE STYLET DISTAL TIP. NO EVIDENCE OF "BARBS" ON THE STYLET WERE OBSERVED. NO EVIDENCE OF "BARBS" ON THE STYLET COULD BE FELT WHEN MOVING BARE (NOT GLOVED) FINGERS ALONG THE STYLET BODY EVEN AT THE KINK AREAS. THE PHOTOS PROVIDED BY THE CUSTOMER SHOW THE STYLET TIP WITH NO EVIDENCE OF "BARBS", AND THE THREE (3) KINKS IN THE STYLET BODY NEAR THE STYLET TIP. A DEVICE HISTORY RECORD REVIEW DID NOT REVEAL ANY MANUFACTURING RELATED ISSUES. SINCE THE REPORTED ISSUE WAS NOT CONFIRMED, NO FURTHER ACTION IS REQUIRED. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    IT WAS REPORTED "THE PICC WAS NOT ADVANCING DUE TO RESISTANCE. THE INSERTER WHO WAS PLACING THE PICC WAS DELIBERATE IN WORKING WITH THE STYLET, BUT AFTER 2 ATTEMPTS TO PULL BACK THE STYLET BY ~ 1CM, SHE MET WITH NO MOVEMENT OF THE STYLET. SHE COULD NOT PULL OUT THE CATHETER OR THE STYLET INITIALLY. AFTER WARMING UP THE VESSEL BY APPLYING HEAT TO THE INSERTION TRACK, SHE CAREFULLY PULLED BACK THE CATHETER AND STYLET. WHEN THE CATHETER AND STYLET WERE OUT OF THE PATIENT THE INSERTER AND THE RESOURCE NURSE SAW THAT THE STYLET HAD PUNCTURED A HOLE IN THE CATHETER AT ~THE 27.5 CM MARK AND THE STYLET WAS HOOKED AT THE TIP OF THE CATHETER. WHEN WE PULLED THE STYLET OUT TO MEASURE AND ASSESS THAT THE NAVICURE TIP WAS INTACT, THEY COULD FEEL AND VISIBLY SEE THAT THERE WERE SHARP BARBS (APPROXIMATELY 5) NEAR THE DISTAL TIP OF THE STYLET." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00658 AND 9680794-2025-00659.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2497526 ARROW PI PICC NAVICURVE: 1L 4FR X 55CM W BP CATHETER, INTRAVASCULAR, THERA LJS ARROW INTERNATIONAL LLC 33F24F0637 10801902208757

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NOT REPORTED