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

Model Number	M0066201210
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The software would not allow me to add a health effect - impact code.Appropriate coding from the resources is no health consequences or impact (2199).
Event or Problem Description
Per email, it was reported that: the moveable core went through the outer sheath of the wire w 3 consecutive wires.Eventually the wires were thrown away and an alternative (non-j tip) wire was used.Device 1 of 3.

• 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
• MDR Report Key: 10518345
• Report Number: 9681477-2020-00010
• Device Sequence Number: 14366603
• Product Code: DQX
• UDI-Device Identifier: 08714729011408
• UDI-Public: (01)08714729011408(17)240531(10)5746976
• 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
• Report Date (Section B): 08/28/2020

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: 06/30/2024
• Device Model Number: M0066201210
• Device Catalogue Number: 620-100
• Device Lot Number: 5889728
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2020
• Initial Report FDA Received Date: 09/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1