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

Catalog Number	AW-16402
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "picu app was placing a line using the arrow spring-wire guide with arrow advancer.During the placement, the wire frayed causing failure of the line placement." no retained material was evaluated.The patient was restuck for line placement.The patient current condition is reported as "fine".
Additional Manufacturer Narrative
Qn#(b)(4) the report that the guide wire separated was confirmed through examination of the returned sample.The customer returned one guide wire and the product packaging for evaluation.Signs-of-use were observed on the returned guide wire.The guide wire was observed to be separated.Visual inspection revealed the guide wire was separated into two segments near the distal end.No significant kinking was observed on the core wire segments.Microscopic examination confirmed the damage.Both welds were present at the ends of the core wire segments and appeared full and spherical.The guide wire segments measured 668mm and 10mm via calibrated ruler, totalling 678mm, which was within the specifications of 677.8-687.4mm per product drawing.The guide wire outer diameter (od) measured 0.44mm via calibrated caliper which was within the specifications of 0.432-0.457mm per product drawing.Functional inspection of the guide wire could not be performed due to the damage.A manual tug test confirmed the distal and proximal welds were intact.The instructions-for-use (ifu) provided with this kit warns the user, "precaution: if resistance is encountered when attempting to remove spring-wire guide after catheter placement, spring-wire may be kinked about tip of catheter within vessel.To minimize the risk of spring-wire guide damage withdraw catheter relative to spring wire guide about 2-3 cm and attempt to remove spring-wire guide.If resistance is again encountered remove spring-wire guide and catheter simultaneously." a device history record review was performed, and no relevant findings were identified.Arrow guide wires of this size are designed and manufactured to withstand a tensile force of 2.0 pounds 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
It was reported "picu app was placing a line using the arrow spring-wire guide with arrow advancer.During the placement, the wire frayed causing failure of the line placement." no retained material was evaluated.The patient was restuck for line placement.The patient current condition is reported as "fine".

• Brand Name: ARROW SPRING WIRE GUIDE COMPONENT
• Common Device Name: WIRE GUIDE 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18627979
• Report Number: 9680794-2024-00075
• Device Sequence Number: 8093029
• Product Code: DQX
• UDI-Device Identifier: 10801902122541
• UDI-Public: 10801902122541
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K810675
• 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): 01/14/2024

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: 02/29/2024
• Device Catalogue Number: AW-16402
• Device Lot Number: 14F19C0055
• 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: 01/14/2024
• Supplement Date Received by Manufacturer: 02/27/2024
• Initial Report FDA Received Date: 02/01/2024
• Supplement Report FDA Received Date: 02/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2019
• 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: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown