MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI CVC KIT: 3-L 7 FR X 16 CM AGB; CATHETER,INTRAVASCULAR,THERAPE

Catalog Number	CDC-42703-XPCN1A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "the wire was advanced into the vein, and ultrasound confirm venous placement of the wire.Unfortunately, on removal on the needle, the tip of the wire became frayed.As such it was unsafe to use this wire, it was promptly removed, and i obtained a new sterile wire.After a new needlestick, i threaded a new wire into the internal jugular and confirm venous placement by ultrasound.Subsequently a skin nick was performed, and the needle tract was dilated.The catheter was then threaded smoothly over the guide wire and the guide wire was removed.Appropriate blood return was obtained each lumen of the catheter was evacuated of air and flushed with sterile saline.The catheter was then sutured in place to the skin and a sterile dressing applied.The patient tolerated the procedure well and there were no complications.Blood loss was minimal." there was no patient harm or injury.No medical intervent ion required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The customer returned one guide wire, an arrow raulerson syringe (ars), and an 18ga introducer needle for analysis.Signs of use were observed on the returned components.Visual analysis revealed the guide wire was unraveled at the distal end.Microscopic examination of the guide wire confirmed the separation.The distal end of the core wire was broken and protruding out of the coil wire.The distal j-bend was misshapen but intact.The proximal weld was present and appeared full and spherical.The distal weld was separated from the distal coil wire and was not returned.No defects or anomalies were observed on the introducer needle.The broken core wire measured 603 mm, which is within the specification limits of 600-608 mm per guide wire product drawing; therefore, no pieces of the core wire appear to be missing.The guide wire outer diameter measured 0.790 mm, which is within the specification limits of 0.788-0.826 mm per guide wire product drawing.The inner diameter of the needle cannula measured 0.041", which is within the specification limits of 0.0410"-0.0430" per cannula product drawing.The guide wire and introducer needle were functionally tested per the product instructions-for-use (ifu).The ifu provided with this kit instructs the user, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle." the functional portion of the guide wire was passed through the returned 18ga introducer needle.The guide wire was able to pass with little to no resistance.A manual tug test confirmed that the proximal weld was secure and intact.A device history record review was performed, and no relevant manufacturing issues were identified.The ifu provided with the kit informs the user, "do not withdraw guidewire against needle bevel to reduce risk of possible severing or damaging of guidewire".The ifu also states, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained and further consultation requested." the report that the guide wire separated was confirmed through complaint investigation of the returned sample.The core wire was broken towards the distal end, but the distal weld was separated from the coil wire and not returned.The guide wire and introducer needle met all functional/dimensional requirements during investigation testing.No manufacturing defects were found during this investigation.Arrow guide wires of this size are designed and manufactured to withstand a tensile force of 2.75 pounds force.This internal specification is higher than the bs en iso 11070:2014 standard of 2.2 pounds force for this size wire.The selected insertion site and patient anatomy may present a tortuous path that could contribute to the possibility of guide wire kinking.Guide wire breakage may occur if a force greater than the design specification is applied during removal.Based on these circumstances, unintentional use error likely caused or contributed to this event; however, the probable cause cannot be determined without the distal weld returned.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "the wire was advanced into the vein, and ultrasound confirm venous placement of the wire.Unfortunately, on removal on the needle, the tip of the wire became frayed.As such it was unsafe to use this wire, it was promptly removed, and i obtained a new sterile wire.After a new needlestick, i threaded a new wire into the internal jugular and confirm venous placement by ultrasound.Subsequently a skin nick was performed, and the needle tract was dilated.The catheter was then threaded smoothly over the guide wire and the guide wire was removed.Appropriate blood return was obtained each lumen of the catheter was evacuated of air and flushed with sterile saline.The catheter was then sutured in place to the skin and a sterile dressing applied.The patient tolerated the procedure well and there were no complications.Blood loss was minimal." there was no patient harm or injury.No medical intervent ion required.The patient's current condition is reported as "fine".

• Brand Name: ARROW PI CVC KIT: 3-L 7 FR X 16 CM AGB
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20532261
• Report Number: 9680794-2024-01066
• Device Sequence Number: 20914159
• Product Code: FOZ
• UDI-Device Identifier: 10801902162080
• UDI-Public: (01)10801902162080(11)240529(17)260131(10)33F24C0485(21)
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K071538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2024

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: 01/31/2026
• Device Catalogue Number: CDC-42703-XPCN1A
• Device Lot Number: 33F24C0485
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2024
• Supplement Date Received by Manufacturer: 11/05/2024
• Initial Report FDA Received Date: 10/25/2024
• Supplement Report FDA Received Date: 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2024
• 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: NONE REPORTED.; NONE REPORTED.
• Patient Age: 29 YR
• Patient Sex: Female
• Patient Weight: 49 KG