MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AGBA PICC NAVICURVE: 2L 5.5FR X 55CM TCG; CATHETER, INTRAVASCULAR, THERA

Catalog Number	DLX-45552-CURVC
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
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.
Additional Manufacturer Narrative
(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.
Event or Problem Description
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.

• Brand Name: ARROW AGBA PICC NAVICURVE: 2L 5.5FR X 55CM TCG
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21168959
• Report Number: 9680794-2025-00002
• Device Sequence Number: 11831259
• Product Code: LJS
• UDI-Device Identifier: 10801902208733
• UDI-Public: (01)10801902208733(11)240926(17)260227(10)33F24E0622(21)
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K220363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/27/2026
• Device Catalogue Number: DLX-45552-CURVC
• Device Lot Number: 33F24E0622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2024
• Supplement Date Received by Manufacturer: 01/27/2025
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 01/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2024
• 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.; NOT REPORTED.
• Patient Sex: Unknown