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

Model Number	M0066201050
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Per salesforce complaint id (b)(4), it was reported that: physician was having difficulty passing stent over wire.Withdrew both stent and wire, noted stent bunched up on wire, cut stent off.Wire appeared elongated.- device issues or patient complications? only device performance issue(s) - what troubleshooting steps took place? replaced wire.

• 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: 11514788
• Report Number: 9681477-2021-00003
• Device Sequence Number: 3431088
• Product Code: DQX
• UDI-Device Identifier: 08714729012634
• UDI-Public: (01)08714729012634(17)241031(10)5981404
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/18/2021

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: 10/31/2024
• Device Model Number: M0066201050
• Device Catalogue Number: 620-105
• Device Lot Number: 5981404
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 03/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1