MAUDE Adverse Event Report: LAKE REGION MEDICAL LIMITED STARTER¿ GUIDEWIRE; WIRE, GUIDE, CATHETER

Model Number	M001491651
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Mid 40¿s male with past history of covid and recent chest pain.Procedure: left cardiac cath and percutaneous transluminal angioplasty.The boston scientific starter guidewire developed a ringlet that peeled back just distal from the j tip.It was removed without known harm to the patient.

• Brand Name: STARTER¿ GUIDEWIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): LAKE REGION MEDICAL LIMITED; 13024 north main st; trenton GA 30752
• MDR Report Key: 12877728
• Report Number: 12877728
• Device Sequence Number: 4780197
• Product Code: DQX
• UDI-Device Identifier: 08714729743330
• UDI-Public: (01)08714729743330(17)240731(10)6473245
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/18/2021
• Report Date (Section F): 11/18/2021

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 Model Number: M001491651
• Device Catalogue Number: 49-165
• Device Lot Number: 6473245
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/26/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/26/2021
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 97 KG
• Date Report Sent to FDA: 11/18/2021