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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Thrombosis/Thrombus (4440)
Date of Event	12/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) the catheter returned one, two-lumen picc for analysis.Signs of use were observed on and within the catheter body, and the distal end of the catheter appeared to be intentionally severed and was not returned.Visual analysis revealed a kink approximately 2 cm from the juncture hub, which matches the customer report that 2 cm of the picc was external to the patient.The kink in the catheter measured 1.8 cm from the juncture hub.The length of the catheter body measured 43.5 cm, which is not within the specification limits of 55.86-57.77 cm per catheter product drawing; therefore, at least 12.36 cm of the catheter was severed and not returned.The outer diameter of the catheter body measured 0.073", which is within the specification limits of 0.069"-0.074" per catheter product drawing.The catheter was functionally tested per the product instructions for use (ifu).The ifu provided with this kit instructs the user, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." the returned catheter was flushed with water using a lab inventory syringe.Both lumens were able to flush with no resistance and there were no functional defects observed with the returned catheter.The customer stated that the catheter was functional within the patient for twenty-one (21) days prior to the reported event.In addition, 2 cm of the picc was reported to be external to the patient.The kink in the catheter was 1.8 cm from the juncture hub, which suggests the catheter became kinked adjacent to the insertion site.The patient also has a prior history of deep vein thrombosis (dvt).A kink in the catheter may lead to thrombosis due to multiple factors such as disruption of blood flow around the catheter, compression of adjacent veins, and endothelial disruption, which can lead to the formation of clots, especially in patients with underlying conditions that increase the risk of catheter-related thrombosis.A device history record review was performed, and no relevant findings were identified.The ifu provided with this kit warns the user, "the antithrombogenic effect of the arrowg+ard blue advance technology on catheters appears to be a function of thrombin inhibition by chlorhexidine via intrinsic and common pathways of blood coagulation, causing delayed blood clotting response and thrombus accumulation on catheter surface.It is not intended to be used for the treatment of existing infections or vein thrombosis.Clinicians must be aware of clinical conditions that may limit use of piccs including, but not limited to: previous ipsilateral venous thrombosis, thrombophlebitis thrombosis, and venous thromboembolism." the ifu also states, "minimize catheter manipulation throughout procedure to maintain proper catheter tip position." the customer report of a catheter thrombosis was confirmed based on complaint investigation of the returned.A kink was observed 1.8 cm from the juncture hub.Despite this, the catheter was able to flush as expected during functional inspection.A device history record review was performed with no relevant findings to suggest a manufacturing related issue.The customer stated that the catheter was functional within the patient for twenty-one (21) days prior to the reported event.In addition, 2 cm of the picc was reported to be external to the patient.The kink in the catheter was 1.8 cm from the juncture hub, which suggests the catheter became kinked adjacent to the insertion site.The patient also has a prior history of deep vein thrombosis (dvt).A kink in the catheter may lead to thrombosis due to multiple factors such as disruption of blood flow around the catheter, compression of adjacent veins, and endothelial disruption, which can lead to the formation of clots, especially in patients with underlying conditions that increase the risk of catheter related thrombosis.The ifu provided with this kit states, "minimize catheter manipulation throughout procedure to maintain proper catheter tip position." based on the customer report and sample received , unintentional use error likely caused or contributed to catheter kink; however, with the patient's past history of dvt, the root cause of thrombosis is undetermined.Teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
It was reported that "picc placed on (b)(6) without event and for tpn.Pt returned to the ed on (b)(6) 2025 reporting picc line was painful, unable to flush line, and occlusion warnings on tpn pump were occurring.When pain during flushing was experienced by patient, rn removed the line.The patient was diagnosed with a dvt (she also had a prior history of dvt).Upon examination of the catheter between the 0 and 1 mark, the catheter material is noted to be very thin.The picc line had 2cm external." there was no patient harm or injury.No medical intervention required.The patient's current condition is unknown at this time.

• 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: keona jones ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 24190882
• Report Number: 9680794-2026-00015
• Device Sequence Number: 13224266
• Product Code: LJS
• UDI-Device Identifier: 10801902208733
• UDI-Public: (01)10801902208733(11)250711(17)261101(10)33F25D0381(21)
• Combination Product (Y/N): N
• 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): 01/01/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: DLX-45552-CURVC
• Device Lot Number: 33F25D0381
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/01/2026
• Initial Report FDA Received Date: 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2025
• 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