MAUDE Adverse Event Report: LAKE REGION MEDICAL LIMITED STARTER GUIDEWIRE

Model Number	M001491181
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/06/2023
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.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", "material fatigue" and/or "improper use" may have impacted on the event as reported.
Event or Problem Description
Event description: it was reported that: difficult removal of the guidewire, which resulted in the severing of the guidewire during removal.During check-up post-procedure, the rest of the guidewire was positioned distally to the in-place drain.Actions taken in the healthcare facility for patient management: the drain and the rest of the guidewire have been removed from the patient.When removing the drain: we had to control the removal of the rest of the guidewire.The device was not conserved.Event date: (b)(6) 2023.
Event or Problem Description
Event description: it was reported that: difficult removal of the guidewire, which resulted in the severing of the guidewire during removal.During check-up post-procedure, the rest of the guidewire was positioned distally to the in-place drain.Actions taken in the healthcare facility for patient management: the drain and the rest of the guidewire have been removed from the patient.When removing the drain: we had to control the removal of the rest of the guidewire.The device was not conserved.Event date: (b)(6).
Additional Manufacturer Narrative
No device was returned for analysis.As reported by customer: 'difficult removal of the guidewire, which resulted in the severing of the guidewire during removal.During check-up post-procedure, the rest of the guidewire was positioned distally to the in-place drain.Actions taken in the healthcare facility for patient management: the drain and the rest of the guidewire have been removed from the patient.When removing the drain: we had to control the removal of the rest of the guidewire.The device was not conserved.'' 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", "material fatigue" and/or "improper use" may have impacted on the event as reported.

• 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: 16282942
• Report Number: 9681477-2023-00001
• Device Sequence Number: 17834210
• Product Code: DQX
• UDI-Device Identifier: 08714729743040
• UDI-Public: (01)08714729743040(17)240930(10)7450718
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2023

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: 09/30/2024
• Device Model Number: M001491181
• Device Lot Number: 7450718
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/25/2023
• Supplement Date Received by Manufacturer: 02/24/2023
• Initial Report FDA Received Date: 02/02/2023
• Supplement Report FDA Received Date: 02/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2022
• 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