MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION BOSTON SCIENTIFIC PLATINUM PLUS GUIDEWIRE WITH GLIDEX HYDROPHILI; WIRE, GUIDE, CATHETER

Model Number	M001467120
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/20/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Pt underwent right brachial angioplasty, right radial artery angioplasty, right ulnar artery angioplasty.Tip of a platinum plus guidewire.014 x 300 cm frayed and broke off.Tip is extramural to brachial artery so it will remain there per dr (b)(6).Dr (b)(6) also stated it would cause more harm than good to remove tip 2/2 pt's health status.Procedure would be an open arm surgical procedure.Fda safety report id# (b)(4).

• Brand Name: BOSTON SCIENTIFIC PLATINUM PLUS GUIDEWIRE WITH GLIDEX HYDROPHILI
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION ; marlborough MA 01752
• MDR Report Key: 9123885
• Report Number: MW5090039
• Device Sequence Number: 16738510
• Product Code: DQX
• UDI-Device Identifier: 08714729486886
• UDI-Public: 08714729486886
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/23/2019

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: M001467120
• Device Lot Number: 23631710
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Weight: 49