MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW SPRING WIRE GUIDE COMPONENT; CATHETER HEMODIALYSIS IMPLANTE

Catalog Number	AW-04435
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "during use, the tip of the needle rebounds." the device was removed and another set was used.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "during use, the tip of the needle rebounds." the device was removed and another set was used.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The customer provided three photos for analysis.The photos show two guide wire advancers within their advancers and kinks were observed at the distal end of both devices.The customer also returned one guide wire within its advancer for analysis.Signs of use were observed on the guide wire.The guide wire was observed to have one kink towards the distal end of the body and an overall curve to the guide wire body.The distal j-bend was misshapen but intact.Microscopic examination confirmed the kinks in the guide wire body.Both welds were present and were observed to be full and spherical.The major kink in the guide wire was located 24 mm from the distal tip.The overall length of the guide wire measured 602 mm, which is within the specification limits of 596-604 mm per guide wire product drawing.The outer diameter of the guide wire measured 0.810 mm, which is not within the specification limits of 0.838-0.877 mm per guide wire product drawing.The guide wire was 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 guide wire was advanced through a lab inventory arrow raulerson syringe (ars) and a lab inventory 18ga introducer needle to functionally test the guide wire.The guide wire passed through both components with little to no resistance.A manual tug test confirmed that both the distal and proximal welds were intact.Manufacturing was contacted as a part of this investigation.They stated the outer diameter of the guide wire is continuously monitored during the coiler manufacturing process.When an outer diameter value outside the specification limits is detected, the machine stops.In addition, the outer diameter of the guide wire is checked using a ring gauge at 1 piece/hr.Therefore, it is probable the reported event is related to manufacturing as a smaller outer diameter may contribute to the guide wire being more prone to kinking.A device history record review was performed and no relevant findings were identified.The ifu provided with the kit describes suggested techniques to minimize the likelihood of guide wire damage during use.The instructions caution , "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 kinked during use was confirmed through complaint investigation of the returned sample.The guide wire had one kink towards the distal tip.The outer diameter of the guide wire measured lower than specifications.The damage observed typically results from undue force used by a clinician during use, however, the dimensional issue with the returned sample may have contributed to the reported event.Based on these circumstances, the root cause is undetermined.A non-conformance was initiated to further investigate the dimensional issue.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "during use, the tip of the needle rebounds." the device was removed and another set was used.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4) section h.11.Amended to the following: the customer provided three photos for analysis.The photos show two guide wire advancers within their advancers and kinks were observed at the distal end of both devices.The customer also returned one guide wire within its advancer for analysis.Signs of use were observed on the guide wire.The guide wire was observed to have one kink towards the distal end of the body and an overall curve to the guide wire body.The distal j-bend was misshapen but intact.It was noted that the markings on the returned guide wire did not match those on product drawing.This suggests either the wrong guide wire was packaged within the kit, or the customer returned the wrong guide wire.Microscopic examination confirmed the kinks in the guide wire body.Both welds were present and were observed to be full and spherical.The major kink in the guide wire was located 24 mm from the distal tip.The overall length of the guide wire measured 602 mm , which is within the specification limits of 596-604 mm per guide wire product drawing.The outer diameter of the guide wire measured 0.810 mm, which is not within the specification limits of 0.838-0.877 mm per guide wire product drawing.Therefore, either the wrong guide wire was packaged within the kit, or the customer returned the wrong guide wire.The guide wire was 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 guide wire was advanced through a lab inventory arrow raulerson syringe (ars) and a lab inventory 18ga introducer needle to functionally test the guide wire.The guide wire passed through both components with little to no resistance.A manual tug test confirmed that both the distal and proximal welds were intact.A device history record review was performed, and there were no additional findings outside of the non-conformance initiated as a result of this complaint investigation.The ifu provided with the kit describes suggested techniques to minimize the likelihood of guide wire damage during use.The instructions caution , "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 kinked during use was confirmed through complaint investigation of the returned sample.The guide wire had one kink towards the distal tip.It was noted that the markings on the returned guide wire did not match those on product drawing.This suggests either the wrong guide wire was packaged within the kit, or the customer returned the wrong guide wire.Based on the condition of the guide wire, unintentional use error likely contributed to this event, however, the root cause cannot be determined as it is undetermined whether the wrong guide wire was packaged within the kit , or if the customer returned the wrong guide wire.A non-conformance was initiated to further investigate this issue.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW SPRING WIRE GUIDE COMPONENT
• Common Device Name: CATHETER HEMODIALYSIS IMPLANTE
• 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: 21847282
• Report Number: 9680794-2025-00305
• Device Sequence Number: 8699468
• Product Code: MPB
• UDI-Device Identifier: 10801902122503
• UDI-Public: (01)10801902122503(11)240306(17)290228(10)14F24C0017(21)
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K993933
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/27/2025

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 Catalogue Number: AW-04435
• Device Lot Number: 14F24C0017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2025
• Supplement Date Received by Manufacturer: 04/16/2025; 07/02/2025
• Initial Report FDA Received Date: 04/16/2025
• Supplement Report FDA Received Date: 04/17/2025; 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2024
• 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: NOT REPORTED; NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown