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

Model Number	RF*RA18183TA
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
[uf medwatch (b)(4).Pdf].
Event or Problem Description
Terumo medical received a user facility medwatch report # (b)(4).The event description states: "terumo guidewire glidewire used to advance through occluded tibial artery.In the process of removing the glidewire the tip broke off in the tibial artery." the original intended procedure was a tibial angioplasty.Additional information was received on 21jul2020.There was no intervention, the tip remained in the occluded tibial artery.The patient's condition was reported to be stable.Patient weight - (b)(6) kg.

• Brand Name: RADIFOCUS GLIDEWIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 10326221
• Report Number: 2243441-2020-00037
• Device Sequence Number: 19100892
• Product Code: DQX
• UDI-Device Identifier: 04987350774194
• UDI-Public: 04987350774194
• 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): 07/27/2020
• Report Date (Section F): 07/27/2020

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: 12/31/2021
• Device Model Number: RF*RA18183TA
• Device Catalogue Number: GM1811
• Device Lot Number: 200107
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/08/2020
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/10/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/27/2020
• 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: Other
• Patient Weight: 46
• Date Report Sent to FDA: 07/27/2020