MAUDE Adverse Event Report: LAKE REGION MEDICAL LIMITED STARTER GUIDEWIRE

Model Number	M001491211
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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.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, "excessive force used" and/or "incompatible device used" appears to have impacted on the event as reported.
Event or Problem Description
Event description: ecn event description: contacted by the lab stating that they had a couple wires from the same box that seemed to start to separate and loose its tip and core functionality.What troubleshooting steps took place? what troubleshooting steps, if any, resolved the issue? na what is the next course of action? investigate device patient present at time of event? yes, patient complications: no patient complications procedure date-unknown event date: no value found as reported device codes: 2446: unraveled material as reported patient codes: 9398: no clinical signs, symptoms or conditions device/procedure outcome: procedure completed, unable to use device - attempted patient outcome: f26: no health consequences or impact as reported device codes: 2446: unraveled material as reported patient codes: 9398: no clinical signs, symptoms or conditions.
Additional Manufacturer Narrative
No device was returned for analysis.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.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, "excessive force used" and/or "incompatible device used" appears to have impacted on the event as reported.
Event or Problem Description
Event description: ecn event description: contacted by the lab stating that they had a couple wires from the same box that seemed to start to separate and loose its tip and core functionality.What troubleshooting steps took place? what troubleshooting steps, if any, resolved the issue?: na what is the next course of action?: investigate device patient present at time of event?: yes patient complications: no patient complications procedure date-unknown event date: no value found as reported device codes: 2446: unraveled material as reported patient codes: 9398: no clinical signs, symptoms or conditions device/procedure outcome: procedure completed,unable to use device - attempted patient outcome: f26: no health consequences or impact as reported device codes: 2446: unraveled material as reported patient codes: 9398: no clinical signs, symptoms or conditions.

• Brand Name: STARTER GUIDEWIRE
• Common Device Name: GUIDEWIRE
• Manufacturer (Section D): LAKE REGION MEDICAL LIMITED; butlersland; new ross; co. wexford, ireland Y34 K 825; EI Y34 K825
• Manufacturer (Section G): LAKE REGION MEDICAL LIMITED; butlersland; new ross; co. wexford, ireland Y34 K 825; EI Y34 K825
• Manufacturer Contact: glenn phelan ; butlersland; new ross; co. wexford Y34 K-825, ; EI Y34 K825,
• MDR Report Key: 20145379
• Report Number: 9681477-2024-00016
• Device Sequence Number: 14512238
• Product Code: DQX
• UDI-Device Identifier: 08714729326540
• UDI-Public: (01)08714729326540(17)270513(10)8450936
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K935170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2024

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 Model Number: M001491211
• Device Lot Number: 8450936
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/23/2024
• Supplement Date Received by Manufacturer: 09/12/2024
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/20/2023
• 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