MAUDE Adverse Event Report: LAKE REGION MEDICAL 0.014" SHEPHERD 30 GUIDEWIRE - STRAIGHT 300 CM - 30 GMS

Model Number	901068-10
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the physician used two shepherd.014" guidewire - straight - 30g and both broke.No additional information was provided.
Additional Manufacturer Narrative
Complaint investigation underway and will be attached to this report.
Additional Manufacturer Narrative
Complaint investigation has been completed as part of this report.
Event or Problem Description
It was reported that the physician used two shepherd.014" guidewire - straight - 30g and both broke.No additional information was provided.

• Brand Name: 0.014" SHEPHERD 30 GUIDEWIRE - STRAIGHT 300 CM - 30 GMS
• Common Device Name: 0.014" SHEPHERD 30 GUIDEWIRE - STRAIGHT 300 CM - 30 GMS
• Manufacturer (Section D): LAKE REGION MEDICAL; parkomore 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: barbara krason ; parkmore west business park; galway, H91 C-K22 ; EI H91 CK22
• MDR Report Key: 22455811
• Report Number: 3006010712-2025-00030
• Device Sequence Number: 8315608
• Product Code: DQX
• UDI-Device Identifier: 10850026568544
• UDI-Public: 10850026568544
• 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): 08/01/2025

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: 901068-10
• Device Catalogue Number: 7-10097-06
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/24/2025
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 08/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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