MAUDE Adverse Event Report: LAKE REGION MEDICAL LIMITED STARTER GUIDEWIRE

Model Number	M001491180
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history records for the specimen device does not present any indication of manufacturing defect or anomaly that could have impacted on the event as reported.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.
Event or Problem Description
Event description: ecn event description: the head of the hemodynamics service reports that when the product was rotated to the table for preparation, the tip of the guide was fractured what troubleshooting steps, if any, resolved the issue?: the problem was solved by using another guide of the same size.What is the next course of action?: replenish the product patient present at time of event?: yes.Patient complications: no patient complications.
Event or Problem Description
Event description: ecn event description: the head of the hemodynamics service reports that when the product was rotated to the table for preparation, the tip of the guide was fractured what troubleshooting steps, if any, resolved the issue?: the problem was solved by using another guide of the same size.What is the next course of action?: replenish the product patient present at time of event?: yes patient complications: no patient complications.
Additional Manufacturer Narrative
No device was returned for analysis.At this time, it is not possible to assign a definitive root cause for the event as reported.Based on the information provided by the supporting documentation, "improper handling in packaging or during removal from packaging" appears to have impacted on the event as reported.
Additional Manufacturer Narrative
The guidewire returned with an open coil at approximately 0.1cm, and an offset at 1.2cm from the distal end of the guidewire.At this time, it is not possible to assign a definitive root cause for the event as reported.Based on the information provided by the supporting documentation, "improper handling in packaging or during removal from packaging" appears to have impacted on the event as reported.
Event or Problem Description
Event description: ecn event description: the head of the hemodynamics service reports that when the product was rotated to the table for preparation, the tip of the guide was fractured.What troubleshooting steps, if any, resolved the issue?: the problem was solved by using another guide of the same size.What is the next course of action?: replenish the product patient present at time of event?: yes, patient complications: no patient complications.

• Brand Name: STARTER GUIDEWIRE
• Common Device Name: GUIDEWIRE
• Manufacturer (Section D): LAKE REGION MEDICAL LIMITED; butlersland; new ross, co. wexford Y34 K 825; EI Y34 K825
• Manufacturer (Section G): LAKE REGION MEDICAL LIMITED; butlersland; new ross, co. wexford Y34 K 825; EI Y34 K825
• Manufacturer Contact: suzanne foley ; butlersland; new ross, co. wexford Y34 K-825 ; EI Y34 K825
• MDR Report Key: 20702653
• Report Number: 9681477-2024-00021
• Device Sequence Number: 12408019
• Product Code: DQX
• UDI-Device Identifier: 08714729201304
• UDI-Public: (01)08714729201304(17)261031(10)7708697
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K935170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/23/2025

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 Model Number: M001491180
• Device Lot Number: 7708697
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/31/2024
• Supplement Date Received by Manufacturer: 11/20/2024; 04/07/2025
• Initial Report FDA Received Date: 11/17/2024
• Supplement Report FDA Received Date: 12/09/2024; 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2023
• 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
• Patient Sex: Unknown