MAUDE Adverse Event Report: LAKE REGION MEDICAL LIMITED WALLSTENT SUPER STIFF GUIDEWIRE

Model Number	H965180011
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2025
Type of Reportable Event	Malfunction
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.The complaint is non-verifiable as the product was not returned for evaluation.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, "difficult patient anatomy", "device interaction", "improper handling" and/or "undetermined cause" appears to have impacted on the event as reported.
Event or Problem Description
Event description: ecn event description: guidewire was placed in patient however when loading dilation balloon onto it, the wire coating stripped from the inner wire what troubleshooting steps took place? what troubleshooting steps, if any, resolved the issue?: guidewire removed and new guidewire was placed what is the next course of action?: guidewire removed and new guidewire was placed patient present at time of event?: yes patient complications: no patient complications time of the event: during procedure what was the outcome of the procedure? procedure completed using an alternate device.

• Brand Name: WALLSTENT SUPER STIFF 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: 21404762
• Report Number: 9681477-2025-00014
• Device Sequence Number: 9382523
• Product Code: KNT
• UDI-Device Identifier: 08714729203070
• UDI-Public: (01)08714729203070(17)270813(10)8524105
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K935198
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/18/2025

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: H965180011
• Device Lot Number: 8524105
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2025
• Initial Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/13/2024
• 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
• Patient Sex: Unknown