MAUDE Adverse Event Report: LAKE REGION MEDICAL LIMITED STARTER GUIDEWIRE

Model Number	M001491471
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2022
Type of Reportable Event	Malfunction
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: na.What troubleshooting steps took place? what troubleshooting steps, if any, resolved the issue?: balloon and wire removed as one.What is the next course of action?: finished procedure with no issue.Patient present at time of event?: yes.Patient complications: no patient complications.In the physician's opinion, did the device or procedure cause or contribute to the patient complication?: no.Patient admitted to hospital beyond the standard of care: no.Patient outcome: fully recovered.Device acquired from a distributor?: no.Event date: (b)(6) 2022.(b)(4).Device/procedure outcome: procedure completed,unable to use device - attempted,different device used (different model).Patient outcome: no health consequences or impact.Procedure date: (b)(6) 2022.Type of procedure: type or procedure: pta.
Additional Manufacturer Narrative
The observation made during the analysis found that the returned guidewire was fractured.The distal end of the returned guidewire was stretched and unravelled.It was noted that full core length including ball weld was returned with the sample.Microscopic examination revealed that the guidewire fractured on the safety ribbon.The distal weld was not present and not found in returned packaging.It was observed that both the core wire and safety ribbon were kinked close to the distal end.The microscopic examination of fracture point noted that the fracture occurred on the safety ribbon close to the distal tip.The ribbon length measured approximately 180.8 cm and matched the guidewire overall length per 6167 drawing.There was evidence of weld heat treat zone close to the fracture point which would indicate that the guidewire was welded on the distal end.Also, there was evidence of necking, which would indicate a ductile fracture.No other damage was present on the retuned guidewire.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" 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, 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: 14682030
• Report Number: 9681477-2022-00010
• Device Sequence Number: 14650427
• Product Code: DQX
• UDI-Device Identifier: 08714729326663
• UDI-Public: (01)08714729326663(17)240930(10)6574318
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 06/13/2022

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: 09/30/2024
• Device Model Number: M001491471
• Device Catalogue Number: 49-147
• Device Lot Number: 6574318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2022
• Initial Report FDA Received Date: 06/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown