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

Catalog Number	DLX-45552-CURVB
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported " the peel away sheath/dilator incident happened at tip of sheath.The sheath mushroomed at tip but also bent the sheath.The inserter held low on the sheath." the picc was placed with a new sheath.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "stable".Associated mdr numbers include: 9680794-2025-00685, 9680794-2025-00686, 9680794-2025-00738.
Additional Manufacturer Narrative
(b)(4) the customer returned one peel-away sheath and dilator assembly for analysis.No definite signs of use were observed on the returned components.Visual analysis revealed that the distal end of the sheath tip was damaged.Additionally, the sheath and dilator were kinked at the same location.The sheath length from the tabs to the distal tip measured 2 3/4", which is within the specification limits of 2 5/8"-2 7/8" per peel-away product drawing.The sheath outer diameter measured 0.0972", 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 dilator length measured 3 7/8", which is within the specification limits of 3 3/4" - 4" per dilator product drawing.The outer diameter of the dilator measured 0.0764", which is within the specification limits of 0.076" - 0.78" per dilator extrusion drawing.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 into the sheath, and locked into the sheath hub.Resistance was encountered at the location of the kink.However, the dilator was still able to pass through the sheath tip.A device history record review was performed, and no potential 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".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 dimensional requirements.Various factors could contribute to the observed damage to the sheath tip, including the sheath tip manufacturing process and/or undue force applied unintentionally by the user, therefore, the root cause is undetermined.A non-conformance was initiated to further investigate potential root causes at the manufacturing site.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported " the peel away sheath/dilator incident happened at tip of sheath.The sheath mushroomed at tip but also bent the sheath.The inserter held low on the sheath." the picc was placed with a new sheath.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "stable".Associated mdr numbers include: 9680794-2025-00685, 9680794-2025-00686, 9680794-2025-00738, and 9680794-2025-00723.

• Brand Name: ARROW AGBA PICC NAVICURVE: 2L 5.5FR X 55CM 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 22951640
• Report Number: 9680794-2025-00723
• Device Sequence Number: 18550888
• Product Code: LJS
• UDI-Device Identifier: 10801902208702
• UDI-Public: (01)10801902208702(11)250205(17)260227(10)33F24L1095(21)
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 08/07/2025

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: 02/27/2026
• Device Catalogue Number: DLX-45552-CURVB
• Device Lot Number: 33F24L1095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2025
• Supplement Date Received by Manufacturer: 09/12/2025
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2025
• 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