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

Model Number	RF*GA35263A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/06/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the involved guidewire was used during the procedure.The hydrophilic coating came off the wire and was left behind in the patient.It was not known until after the fact.The case was completed with no further incident.The procedure outcome was reported to be done.The patient's condition was good.There was no patient injury, medical/surgical intervention required.Additional information was received on 10aug2020.They believe it was the polyurethane coating that was left behind.It was a tips procedure and the case turned out good and they are not concerned about what was left behind.They did not realize what was left behind until after; however, where it was left the tracts was closed up for the transjugular intrahepatic portosystemic shunt (tips) procedure.Additional information was received on 11aug2020.From what they gathered it was the "coating" or plastic jacket.They stated that the case was completed.They were using the cook tips kit.

• 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: 10454498
• Report Number: 2243441-2020-00050
• Device Sequence Number: 4092501
• Product Code: DQX
• UDI-Device Identifier: 04987350773210
• UDI-Public: 04987350773210
• 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): 08/26/2020
• Report Date (Section F): 08/26/2020

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: 06/30/2021
• Device Model Number: RF*GA35263A
• Device Catalogue Number: GR3509
• Device Lot Number: 190722
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/06/2020
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/10/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: COOK TIPS KIT
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 08/26/2020