MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PSI SET: 9 FR; INTRODUCER, CATHETER

Model Number	IPN920646
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	02/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "the guide got blocked in the puncture needle.It was impossible to remove the needle without removing the guide.".The consequence was reported as "unnecessary puncture and failure to insert the catheter.Patient had a hematoma at the puncture point.Device was replaced.".The insertion site was the "inner right jugular".No medical intervention was required to treat the hematoma.Customer reported there was no consequence for the patient.
Additional Manufacturer Narrative
Qn# (b)(4).
Additional Manufacturer Narrative
(b)(4).The customer returned one guide wire, introducer needle, and product lidstock for analysis.Definite signs of use were observed on the returned components.The guide wire was returned lodged within the introducer needle and was removed for further analysis.Once removed, large amounts of blood were found along the guide wire body, likely contributing to the resistance experienced by the customer.Visual analysis revealed multiple kinks along the guide wire body.The distal j-bend appeared misshapen but intact.Microscopic examination confirmed the defect and revealed that both welds are present and full and spherical.No obvious defects or anomalies were found on the needle.The kinks in the guide wire measured 28mm, 208mm, and 432mm from the proximal weld.The overall length of the guide wire measured 455mm which is within the specification limits of 450mm - 458mm per the guide wire product drawing.The outer diameter of the guide wire measured 0.854mm which is within the specification limits of 0.838mm - 0.877mm per the guide wire product drawing.The inner diameter of the needle cannula at the distal tip measured 0.042" which is within the specification limits of 0.041" - 0.043" per the needle cannula drawing.The components were functionally tested per the instructions for use (ifu) provided with this kit, which informs the user "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle (or catheter)." the guide wire was inserted through the introducer needle and a lab inventory syringe once the congealed blood was removed, and the undamaged portions were able to pass with little to no resistance.A manual tug test confirmed that both welds were secure and intact.A device history record review was performed and no relevant findings were identified.The ifu provided with this kit informs the user, "do not apply excessive force in placing or removing guidewire, dilator, or sheath.Excessive force can cause component damage or breakage.".The customer report of a kinked guide wire was confirmed through investigation of the returned sample.Visual analysis revealed multiple kinks along the guide wire body.Large amounts of blood were observed along the length of the guide wire within the needle, likely contributing to the resistance experienced by the customer.The components passed all relevant dimensional and functional requirements, and a device history record review was performed with no relevant findings.Based on the customer report and the sample received, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend on reports of this nature.
Event or Problem Description
It was reported that: "the guide got blocked in the puncture needle.It was impossible to remove the needle without removing the guide.".The consequence was reported as "unnecessary puncture and failure to insert the catheter.Patient had a hematoma at the puncture point.Device was replaced.".The insertion site was the "inner right jugular".No medical intervention was required to treat the hematoma.Customer reported there was no consequence for the patient.

• Brand Name: ARROW PSI SET: 9 FR
• Common Device Name: INTRODUCER, CATHETER
• 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: 16648866
• Report Number: 9680794-2023-00273
• Device Sequence Number: 5516712
• Product Code: DYB
• UDI-Device Identifier: 10801902196351
• UDI-Public: 10801902196351
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K780532
• 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): 03/30/2023

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 Model Number: IPN920646
• Device Catalogue Number: SI-09903-E
• Device Lot Number: 14F22L0011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2023
• Supplement Date Received by Manufacturer: 04/27/2023
• Initial Report FDA Received Date: 03/30/2023
• Supplement Report FDA Received Date: 05/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2022
• 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
• Patient Sex: Unknown