MAUDE Adverse Event Report: TERUMO CORPORATION GLIDEWIRE; WIRE, GUIDE, CATHETER

Model Number	GR3508
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/24/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Pt was on the table having a pericardiocentesis and physician using a terumo guide wire and when the wire was being removed, the distal part of the guidewire was retained in the pericardial space, physician aware w/ no harm to the patient and image captured on flouro in pt chart.

• Brand Name: GLIDEWIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION; 950 elkton blvd; elkton MD 21921
• MDR Report Key: 12158297
• Report Number: 12158297
• Device Sequence Number: 19830566
• Product Code: DQX
• UDI-Device Identifier: 04987350773197
• UDI-Public: (01)04987350773197
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/01/2021
• Report Date (Section F): 07/01/2021

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: GR3508
• Device Catalogue Number: RF*GA35183A
• Device Lot Number: 200604
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/13/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 07/01/2021