MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AGBA PICC/DELTA KIT: 1-L 4.5 FR X 55 CM; CATHETER INTRAVASCULAR THERAPE

Model Number	IPN037306
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "wire has extra paint on the proximal end and made it so the dilator could not be successfully threaded over the wire - defect is visually available".
Additional Manufacturer Narrative
(b)(4).The customer returned a single guide wire and dilator for evaluation.The guide wire was returned within the advancer tube and showed evidence of use.The kink/offset coil in the guide wire was located 19cm from the distal tip.The overall length of the guide wire measured 45cm which is within the specification of 43.75cm - 46.25cm per guide wire product drawing.The outer diameter (od) of the guide wire measured 0.0179" which is within the specification of 0.0160" - 0.0185" per guide wire product drawing.The inner diameter (id) of the dilator tip measured 0.021" which was within specifications 0.020" - 0.022" as per product drawing.The id of the dilator at the proximal end measured 0.023" which was within specifications 0.022" - 0.026" as per the dilator extrusion product drawing.The od of the dilator measured 0.0631" which was within specifications 0.063" - 0.065" as per the dilator extrusion product drawing.Functional testing was performed per ifu statement, "ensure dilator is in position and locked to hub of sheath.Thread peel-away sheath/dilator assembly over guidewire.Grasping near skin, advance peel-away sheath/dilator assembly over guidewire with slight twisting motion to a depth sufficient to enter vessel." the guide wire passed through the dilator with minimal resistance.A manual tug test was performed and confirmed that both the distal and proximal welds were intact.The instructions for use (ifu) provided with this kit warns the user, "precaution: sufficient guidewire length must remain exposed at hub end of sheath to maintain a firm grip on guidewire.Warning: do not apply undue force on guidewire to reduce risk of possible breakage." guide wire kinked during use was confirmed through examination of the returned sample.The guide wire was kinked 19cm from the distal tip.The returned guide wire and dilator met all relevant dimensional and functional requirements, and a device history record review did not identify any manufacturing related issues.Based on the condition of the guide wire and the report that the damage was observed during use, unintentional use error caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW AGBA PICC/DELTA KIT: 1-L 4.5 FR X 55 CM
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• 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: victoria sandlin ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17216227
• Report Number: 9680794-2023-00506
• Device Sequence Number: 3011340
• Product Code: LJS
• UDI-Device Identifier: 50801902120781
• UDI-Public: 50801902120781
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K153487
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/22/2023

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: 03/31/2024
• Device Model Number: IPN037306
• Device Catalogue Number: CDC-45541-VPS2
• Device Lot Number: 33F23B0632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2023
• Initial Report FDA Received Date: 06/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2023
• 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