MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI PICC NAVICURVE: 1L 4FR X 55CM W BP; CATHETER, INTRAVASCULAR, THERA

Catalog Number	DLX-35541-CURVB
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Sharp Edges (4013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
(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.

• Brand Name: ARROW PI PICC NAVICURVE: 1L 4FR X 55CM W BP
• Common Device Name: CATHETER, INTRAVASCULAR, THERA
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: keona jones ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 22715902
• Report Number: 9680794-2025-00658
• Device Sequence Number: 15745502
• Product Code: LJS
• UDI-Device Identifier: 10801902208757
• UDI-Public: (01)10801902208757(11)240930(17)260131(10)33F24F0637(21)
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K220363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 01/31/2026
• Device Catalogue Number: DLX-35541-CURVB
• Device Lot Number: 33F24F0637
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2025
• Initial Report FDA Received Date: 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED
• Patient Sex: Unknown