MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI CVC KIT: 3-L 7 FR X 8" (20 CM); CATHETER INTRAVASCULAR THERAP

Model Number	IPN037093
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The inserting physician noted while advancing the wire through the introducer needle, resistance was encountered.The physician proceeded to remove the wire and needle together and upon removal, noted the j tip had become straight.The physician noted the length of the wire was correct.A new kit was used.No patient harm was reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).The customer provided one photo for analysis.The customer returned one guide wire for analysis.No signs of use were observed on the guide wire.Visual analysis revealed that there were four bends on the guide wire body with three at the distal j-bend causing it to appear misshapen.Microscopic examination revealed that both welds were full and intact.Visual analysis could not be performed on the needle as it was not returned.The bends on the guide wire measured 5mm, 14mm, 22mm, and approximately 30mm from the distal tip.The overall length of the guide wire measured 603mm which is within the specification of 596-604 mm per guide wire product drawing.The outer diameter of the guide wire measured 0.798mm which is within the specification of 0.788mm-0.826mm per guide wire product drawing.The guide wire was functionally tested per the instructions for use (ifu) provided with this kit, which states "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle." the guide wire was inserted through a laboratory ars/introducer needle subassembly and the guide wire was able to pass with little to no difficulty.Functional analysis could not be performed on the needle as it was not returned.A manual tug test confirmed that both the distal and proximal welds were secure and intact.A device history record review was performed, and there was one finding; however, it was determined that the finding was not relevant to this investigation.The instructions for use (ifu) provided with the 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 kinked guide wire was confirmed through examination of the returned sample.Visual examination revealed there were four bends on the guide wire which deformed the j-tip of the guidewire.The introducer needle was not returned.The guide wire met all relevant dimensional and functional requirements.A device history record review was performed, and no relevant findings were identified.Based on these circumstances and the customer description, the root cause could not be determined as the introducer needle was not returned.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
The inserting physician noted while advancing the wire through the introducer needle, resistance was encountered.The physician proceeded to remove the wire and needle together and upon removal, noted the j tip had become straight.The physician noted the length of the wire was correct.A new kit was used.No patient harm was reported.The patient's condition is reported as fine.

• Brand Name: ARROW PI CVC KIT: 3-L 7 FR X 8" (20 CM)
• Common Device Name: CATHETER INTRAVASCULAR THERAP
• 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: 17304967
• Report Number: 9680794-2023-00507
• Device Sequence Number: 17931561
• Product Code: FOZ
• UDI-Device Identifier: 10801902119985
• UDI-Public: 10801902119985
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K071538
• 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,Followup
• Report Date (Section B): 06/16/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2024
• Device Model Number: IPN037093
• Device Catalogue Number: NA-15703-PCDC
• Device Lot Number: 13F22M0298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2023
• Supplement Date Received by Manufacturer: 07/31/2023
• Initial Report FDA Received Date: 07/12/2023
• Supplement Report FDA Received Date: 08/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown