MAUDE Adverse Event Report: LAKE REGION MEDICAL LIMITED BENTSON TYPE PTFE COATED GUIDEWIRE

Model Number	M0066201250
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No device was provided for analysis.As reported by customer: "during the case a small piece of the end of the wire broke off, broken piece was retrieved''.A review of the device history records of 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 "improper use" may have impacted on the event as reported.
Event or Problem Description
Event description: please provide a brief summary of the event that includes any additional details that you have not already provided: during the case a small piece of the end of the wire broke off, broken piece was retrieved.What troubleshooting steps took place? what troubleshooting steps, if any, resolved the issue?: retrieved the broken piece.What is the next course of action?: opened a new wire.Patient present at time of event?: yes.Patient complications: no patient complications.

• Brand Name: BENTSON TYPE PTFE COATED 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: 13865272
• Report Number: 9681477-2022-00003
• Device Sequence Number: 5272465
• Product Code: DQX
• UDI-Device Identifier: 08714729056669
• UDI-Public: (01)08714729056669(17)250930(10)6582044
• Combination Product (Y/N): N
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/22/2022

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 Expiration Date: 09/30/2025
• Device Model Number: M0066201250
• Device Catalogue Number: 620-125
• Device Lot Number: 6582044
• 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: 03/02/2022
• Initial Report FDA Received Date: 03/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2021
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown