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	02/23/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly male with history of hypertension and recent chest pain.Procedure is percutaneous intervention-balloon angioplasty with stent placement.When the package of the boston scientific guidewire was opened, the j wire was broken/bent.Not used on patient.

• Brand Name: STARTER GUIDEWIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): LAKE REGION MEDICAL LIMITED; 340 lake hazeltine dr; chaska MN 55318
• MDR Report Key: 11398606
• Report Number: 11398606
• Device Sequence Number: 14578428
• Product Code: DQX
• UDI-Device Identifier: 08714729743330
• UDI-Public: (01)08714729743330(17)231130(10)5999760
• 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): 02/23/2021
• Report Date (Section F): 02/23/2021

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: 5999760
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/02/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/02/2021
• Patient Sequence Number: 1
• Patient Weight: 77
• Date Report Sent to FDA: 02/23/2021