MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA RADIFOCUS GUIDEWIRE OR GLIDEWIRE OR GLIDEWIRE M; WIRE, GUIDE, CATHETER

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/24/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the doctor used the glidewire through a needle into the pericardium and it appeared that part of it became sheared off.The piece was left in the patient and then appears to be no issues with the patient due to this occurrence.It was not removed.Terumo medical received a user facility medwatch report # (b)(4).The event description states: "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 fluoro in pt chart." the original intended procedure was a pericardiocentesis.The location where the event occurred was the electrophysiology lab.

• Brand Name: RADIFOCUS GUIDEWIRE OR GLIDEWIRE OR GLIDEWIRE M
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 12202984
• Report Number: 2243441-2021-00030
• Device Sequence Number: 4440992
• Product Code: DQX
• UDI-Device Identifier: 04987350773197
• UDI-Public: 04987350773197
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/21/2021
• Report Date (Section F): 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: N/A
• Device Catalogue Number: GR3508
• Device Lot Number: 200604
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/01/2021
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/06/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 85 YR
• Date Report Sent to FDA: 07/21/2021