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

Catalog Number	AW-14735
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "during a mac introducer placement, the fellow needed an additional guide wire to place the central line.An additional guide wire of the same size was retrieved from the procedure cart.After placement of the central line, the guide wire was removed without resistance.However, upon further inspection, the guide wire appeared to be shorter in length and uncoiled at the end with a smaller diameter.The distal end of the guide wire was visualized in the left ij via ultrasound.Ir was notified and the patient was taken to ir for foreign body removal.The distal portion of the guide wire 8 inches was removed."marked spring-wire guide with arrow advancer".0.035 inch diameter spring-wire guide (68 cm swg)" the patient was reported as "fine".
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: "during a mac introducer placement, the fellow needed an additional guide wire to place the central line.An additional guide wire of the same size was retrieved from the procedure cart.After placement of the central line, the guide wire was removed without resistance.However, upon further inspection, the guide wire appeared to be shorter in length and uncoiled at the end with a smaller diameter.The distal end of the guide wire was visualized in the left ij via ultrasound.Ir was notified and the patient was taken to ir for foreign body removal.The distal portion of the guide wire 8 inches was removed."marked spring-wire guide with arrow advancer".0.035 inch diameter spring-wire guide (68 cm swg)" the patient was reported as "fine".

• Brand Name: SPRING WIRE GUIDE COMPONENT
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• 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: 19320581
• Report Number: 9680794-2024-00457
• Device Sequence Number: 6358139
• Product Code: FOZ
• UDI-Device Identifier: 10801902122534
• UDI-Public: 10801902122534
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K970864
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: AW-14735
• Device Lot Number: 14F24A0153
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2024
• Supplement Date Received by Manufacturer: 06/06/2024
• Initial Report FDA Received Date: 05/15/2024
• Supplement Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2024
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown