MAUDE Adverse Event Report: LAKE REGION MEDICAL 0.014 SHEPHERD ES GUIDEWIRE - STRAIGHT 300 CM - 4 GMS

Model Number	901068-02
Medical Device Problem Codes	Material Integrity Problem (2978); Device Handling Problem (3265)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint investigation underway and will be attached to this report.
Event or Problem Description
A wire exchanged was performed for a shepherd guide wire to treat a moderately calcified, non-tortuous, 50% stenosed lesion in posterior tibial artery (pt) through common femoral artery (cfa).During treatment, the wire became stuck.The wire was pulled to loosen it from the vessel.Fluoroscopy imaging was performed and revealed the tip of the wire had fractured.The fractured component was too small to be snared and was left in vivo.There was no indication why the wire fractured.The patient was stable with no complications.
Event or Problem Description
A wire exchanged was performed for a shepherd guide wire to treat a moderately calcified, non-tortuous, 50% stenosed lesion in posterior tibial artery (pt) through common femoral artery (cfa).During treatment, the wire became stuck.The wire was pulled to loosen it from the vessel.Fluoroscopy imaging was performed and revealed the tip of the wire had fractured.The fractured component was too small to be snared and was left in vivo.There was no indication why the wire fractured.The patient was stable with no complications.

• Brand Name: 0.014 SHEPHERD ES GUIDEWIRE - STRAIGHT 300 CM - 4 GMS
• Common Device Name: 0.014 SHEPHERD ES GUIDEWIRE - STRAIGHT 300 CM - 4 GMS
• Manufacturer (Section D): LAKE REGION MEDICAL; parkmore west business park; galway, H91 C K22; EI H91 CK22
• Manufacturer (Section G): LAKE REGION MEDICAL; parkmore west business park; galway, H91 C K22; EI H91 CK22
• Manufacturer Contact: amy carter ; parkmore west business park; galway, H91 C-K22 ; EI H91 CK22
• MDR Report Key: 21729454
• Report Number: 3006010712-2025-00015
• Device Sequence Number: 8626284
• Product Code: DQX
• UDI-Device Identifier: 10850026568544
• UDI-Public: (01)10850026568544(17)260531(10)8208032
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K120137
• 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: Administrator/Supervisor
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2025

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: 901068-02
• Device Catalogue Number: 7-10096-02
• Device Lot Number: 8208032
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/18/2025
• Supplement Date Received by Manufacturer: 03/18/2025
• Initial Report FDA Received Date: 03/31/2025
• Supplement Report FDA Received Date: 05/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2023
• 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