MAUDE Adverse Event Report: LAKE REGION MEDICAL LIMITED STARTER GUIDEWIRE

Model Number	M001491211
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product was provided for the analysis.As reported by the customer, "merced vascular, and vein center reached out to bsc representative today, and said this wires tip frayed and the tip fell off.'' 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
It was reported that, "merced vascular and vein center reached out to bsc representative today, and said this wires tip frayed, and the tip fell off.".
Event or Problem Description
It was reported that: merced vascular and vein center reached out to bsc representative today and said this wires tip frayed and the tip fell off.
Additional Manufacturer Narrative
Device was returned after being informed it would not, device evaluation completed and report updated accordingly.

• 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
• MDR Report Key: 10676609
• Report Number: 9681477-2020-00014
• Device Sequence Number: 14197093
• Product Code: DQX
• UDI-Device Identifier: 08714729743071
• UDI-Public: (01)08714729743071(17)230531(10)5810240
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 11/30/2020

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: 05/31/2023
• Device Model Number: M001491211
• Device Lot Number: 5810240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2020
• Initial Date Received by Manufacturer: 09/24/2020
• Supplement Date Received by Manufacturer: 11/02/2020
• Initial Report FDA Received Date: 10/14/2020
• Supplement Report FDA Received Date: 11/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1