MAUDE Adverse Event Report: LAKE REGION MEDICAL LIMITED STARTER GUIDEWIRE

Model Number	M001491181
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Per email, it was reported that: starter wire looks deformed before use.Here is some additional information on the guidewire.05aug2021 jlc: response received from gayathry n vadival on 02aug2021 what was the anatomy location that the physician was working on? left main to lad.Please provide lesion details: % stenosis? left main 50%, lad 70%.Calcification? (not calcified, mild, moderate, severe).Concentric calcium in left main, intimal calcification at lad.Tortuosity? (not tortuous, mild, moderate, severe).Not stated.When is the expected date this device will be returned? by this month.

• 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: 12545507
• Report Number: 9681477-2021-00015
• Device Sequence Number: 17429881
• Product Code: DQX
• UDI-Device Identifier: 08714729743040
• UDI-Public: (01)08714729743040(17)231130(10)5999717
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/29/2021

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: 11/30/2023
• Device Model Number: M001491181
• Device Lot Number: 5999717
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2021
• Initial Report FDA Received Date: 09/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1