MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 5.5 FR X 13 CM; CATHETER PERCUTANEOUS

Model Number	IPN036093
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The complaint is reported as: "on (b)(6) 2023 during the proceedings of ultrasound-guided cannulation of the right jugular vein, the carotid artery was mistakenly cannulated.The error was noticed only at the end of the surgery and the device was removed and correctly inserted into the right jugular vein.On (b)(6), doing a control radiography, they noticed the presence of a fragment (probably of seldinger) in the aorta.The fragment was removed in surgery without complications for the patient, who was discharged the following day." the patient's current condition is reported as fine.
Additional Manufacturer Narrative
Qn#(b)(4).
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one portion of a guide wire for evaluation.The guide wire was returned with a broken core and coil wire and the separated portion was not returned.Visual inspection of the guide wire revealed offset coils near the point of separation.The guide wire was separated approximately 1" from the proximal end based on the returned sample.Microscopic examination confirmed the complaint of guide wire separation.The core wire point of separation was near the proximal end of the wire.The spring coil point of separation was at the distal end of the wire.The proximal weld was present at the end of the wire and was full and spherical.Offset coils measured at 1/8" from the proximal end of the guide wire.The core wire total length measured 1 and 1/8", which is out of the specification of 17 11/16" - 18 1/16" per product drawing.This indicates that the majority of the core wire was missing from the returned sample.The guide wire outer diameter measured 0.0180", which is within the specifications of 0.0170-0.0180" per product drawing.Functional inspection of the guide wire could not be performed due to the condition of the returned sample.A manual tug test confirmed that the proximal weld was fully secured onto the guide wire.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.No relevant findings were identified.The instructions for use (ifu) provided with this kit warns the user, "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 customer report of a separated guide wire was confirmed through complaint investigation of the returned sample.The returned guide wire was observed to be separated approximately 1" from the proximal end.The proximal end of wire was returned with offset coils near the point of separation.Dimensional evaluation of the returned components did not reveal any evidence of a manufacturing dimensional issue.A device history record review was performed based on a potential lot from sales history with no relevant findings.Arrow guide wires of this size are designed and manufactured to withstand a tensile force of 2.0 pounds of force.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 caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
The complaint is reported as: "on (b)(6) 2023 during the proceedings of ultrasound-guided cannulation of the right jugular vein, the carotid artery was mistakenly cannulated.The error was noticed only at the end of the surgery and the device was removed and correctly inserted into the right jugular vein.On (b)(6), doing a control radiography, they noticed the presence of a fragment (probably of seldinger) in the aorta.The fragment was removed in surgery without complications for the patient, who was discharged the following day." the patient's current condition is reported as fine.

• Brand Name: ARROW CVC SET: 3-LUMEN 5.5 FR X 13 CM
• Common Device Name: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17599761
• Report Number: 3006425876-2023-00815
• Device Sequence Number: 20425537
• Product Code: DQY
• UDI-Device Identifier: 30801931122981
• UDI-Public: 30801931122981
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2023

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?: Yes
• Device Model Number: IPN036093
• Device Catalogue Number: CS-16553-E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2023
• Supplement Date Received by Manufacturer: 09/19/2023
• Initial Report FDA Received Date: 08/22/2023
• Supplement Report FDA Received Date: 09/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown