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

Model Number	RF*GA38153A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Information (3190)
Date of Event	07/21/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the doctor inserted the glidewire through his access needle and it sheared off about 30-40cm of the jacket of the wire.The doctor had to access the opposite femoral artery to retrieve the detached sleeve with a snare.The patient's condition was stable.There was no patient injury, medical/surgical intervention required.Additional information was received on 23jul2020.An angio procedure was being performed.They are not aware that any of the glidewire was left in the patient.Fluoroscopy was used to snare the jacket.There was no harm to the patient.Once jacket portion was snared, they finished getting their imaging.

• 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: 10355831
• Report Number: 2243441-2020-00045
• Device Sequence Number: 14043431
• Product Code: DQX
• UDI-Device Identifier: 04987350773357
• UDI-Public: 04987350773357
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/03/2020
• Report Date (Section F): 08/03/2020

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: 02/28/2021
• Device Model Number: RF*GA38153A
• Device Catalogue Number: GR3806
• Device Lot Number: 190314
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/22/2020
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/23/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/03/2020
• 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: Required Intervention
• Date Report Sent to FDA: 08/03/2020