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 Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "during picc line placement the peel-away sheath sheared during placement.An mst kit was opened to obtain another peel-away sheath which was successfully placed.The patient was in her 20's and had 'tough' skin and it was difficult to access her vein secondary to moving/toughness of vessel wall." there was no patient harm or injury.No medical intervention required.A replacement sheath was used without incident.The patient's current condition is reported as "unknown".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one peel-away sheath with dilator assembly for analysis.Signs of use were observed on the sheath and dilator.Visual analysis revealed that the distal end of the sheath tip was damaged.No other defects were observed with the dilator.The sheath length from the tabs to the distal tip measured approximately 2 13/16" , which is within the specification limits of 2 5/8"-2 7/8" per peel-away product drawing.The sheath outer diameter measured 0.099", which is within the specification limits of 0.097"-0.102" per peel-away extrusion product drawing.The sheath inner diameter at the distal tip could not be accurately measured due to the nature of the damage.The peel-away sheath and dilator were functionally tested per the product instructions for use (ifu).The ifu provided with this kit instructs the user , "ensure dilator is in position and locked to hub of sheath." the dilator was removed, reinserted back into the sheath, and locked into the sheath hub.The dilator was able to pass through the sheath tip with little to no resistance.Manufacturing was contacted as a part of this complaint investigation.They stated that based on the customer report that the patient had "tough" skin and there was difficulty navigating through the vessel wall , undue force likely caused or contributed to the reported event.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not use excessive force when introducing guidewire, peel-away sheath over tissue dilator, or tissue dilator as this can lead to venospasm, vessel perforation, bleeding , or component damage.If necessary, enlarge cutaneous puncture site with cutting edge of scalpel, positioned away from guidewire.Insert catheter through peel-away sheath to final indwelling position.Retract and/or gently flush while advancing catheter if resistance is met." the report of peel-away body damage was confirmed through complaint investigation of the returned sample.Visual analysis revealed that the sheath tip was damaged.Despite the damage, the sheath and the dilator met all relevant functional requirements.Information from the customer suggests the insertion site was "tough", of which the ifu informs the user, "if necessary, enlarge cutaneous puncture site with cutting edge of scalpel, positioned away from guidewire." based on the customer report that the patient had "tough" skin and there was difficulty navigating through the vessel wall, undue force likely caused or contributed to the reported event.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "during picc line placement the peel-away sheath sheared during placement.An mst kit was opened to obtain another peel-away sheath which was successfully placed.The patient was in her 20's and had 'tough' skin and it was difficult to access her vein secondary to moving/toughness of vessel wall." there was no patient harm or injury.No medical intervention required.A replacement sheath was used without incident.The patient's current condition is reported as "unknown".

• 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: 22436227
• Report Number: 9680794-2025-00569
• Device Sequence Number: 20010770
• Product Code: LJS
• UDI-Device Identifier: 10801902208733
• UDI-Public: (01)10801902208733(11)250131(17)260606(10)33F24L0982(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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2025

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: 06/06/2026
• Device Catalogue Number: DLX-45552-CURVC
• Device Lot Number: 33F24L0982
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2025
• Supplement Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2025
• 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.; NOT REPORTED.
• Patient Sex: Unknown