MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 16 CM; CATHETER HEMODIALYTSIS NON IMP

Model Number	IPN919778
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported during the procedure, the physician found the guidewire kinked and bent.A new kit was opened to finish the procedure and procedure was successfully completed.No patient harm was reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned multiple components from a cvc kit and a lidstock for analysis.The guide wire will be analyzed as part of this investigation.Signs of use in the form of biological material were observed on the guide wire body.Visual analysis revealed that the guide wire contained a small kink/offset coil towards the distal end.Microscopic examination confirmed the damage and revealed that the distal and proximal welds were spherical and intact.The kinks in the guide wire measured 575mm from the proximal weld.The guide wire total length measured 602mm, which is within the specification limits of 596mm-604mm per the guide wire product drawing.The guide wire outer diameter measured.838mm, which is within the specification limits of.838mm-.877mm per the guide wire product drawing.The guide wire was able to pass through the returned arrow raulerson syringe (ars)/introducer needle subassembly.Minor resistance was encountered due to the kinking on the guide wire; however, it was able to pass completely through the ars/needle subassembly.Performed per ifu statement, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle".A manual tug test confirmed that the distal and proximal welds were secure and intact.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs 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 complaint investigation.Visual analysis revealed one major kink on the guide wire.Despite the damage, the guide wire met 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 for reports of nature.
Event or Problem Description
It was reported during the procedure, the physician found the guidewire kinked and bent.A new kit was opened to finish the procedure and procedure was successfully completed.No patient harm was reported.The patient's condition is reported as fine.

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 16 CM
• Common Device Name: CATHETER HEMODIALYTSIS NON IMP
• 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: 15845906
• Report Number: 3006425876-2022-01080
• Device Sequence Number: 6996371
• Product Code: MPB
• UDI-Device Identifier: 10801902191158
• UDI-Public: 10801902191158
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K993933
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2022

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: 06/02/2023
• Device Model Number: IPN919778
• Device Catalogue Number: CS-22122-F
• Device Lot Number: 71F21K1372
• 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: 11/01/2022
• Supplement Date Received by Manufacturer: 12/07/2022
• Initial Report FDA Received Date: 11/22/2022
• Supplement Report FDA Received Date: 12/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2021
• 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