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

Model Number	M0066201010
Medical Device Problem Codes	Fracture (1260); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history records of the specimen 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 integer and was determined to be acceptable.
Event or Problem Description
Per email, it was reported that: as the doctor went to use the item during a case, he noticed that the fiber was fractured in the plastic holder.
Additional Manufacturer Narrative
Device evaluation completed and codes updated.
Event or Problem Description
Per email, it was reported that: as the doctor went to use the item during a case, he noticed that the fiber was fractured in the plastic holder.

• 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: 10892128
• Report Number: 9681477-2020-00021
• Device Sequence Number: 19556937
• Product Code: DQX
• UDI-Device Identifier: 08714729005711
• UDI-Public: (01)08714729005711(17)240630(10)5834732
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2020

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: M0066201010
• Device Catalogue Number: 620-101
• Device Lot Number: 5834732
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Initial Date Received by Manufacturer: 11/05/2020
• Supplement Date Received by Manufacturer: 11/16/2020
• Initial Report FDA Received Date: 11/24/2020
• Supplement Report FDA Received Date: 12/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1