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

Model Number	RF*GA35183A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	01/28/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the glidewire sheared off in a tips procedure.The glidewire tip was left in patient overnight and removed with snare the next day.The blood loss was less than 250 cc's.The patient required removal of glidewire tip through endovascular procedure.The tips procedure was a success; however, the patient passed away the following day from bleeding gastric varices.Additional information received on 06feb2020.The doctor did not feel that the sheared off glidewire tip led or caused the death of the patient; the patient had severe liver failure and passed due to liver insufficiency and cholangitis.The tip of the glidewire separated in the pulmonary artery.The sheared tip did not cause a rupture in the vessel it was embedded in; 1cm wire core and 1cm outer covering were successfully removed with a snare.After the tip was snared and removed the next day, the patient was in stable condition, and the tips procedure was performed afterwards.The tips procedure was not successful; liver was severely cirrhotic and portal vein was tiny.Other co-morbidities the patient had was hepatic insufficiency (meld score 20) and was admitted to the hospital with severe gastric plus esophageal bleed prior to procedure.The patient had dnr status.The cause of the patient's death was severe sepsis, hepatic failure with inr rising from 2 to over 4 and rising t.Bilirubin levels to 4; renal failure.

• 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: 9770437
• Report Number: 2243441-2020-00012
• Device Sequence Number: 2372974
• Product Code: DQX
• UDI-Device Identifier: 04987350773197
• UDI-Public: 04987350773197
• 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): 02/28/2020
• Report Date (Section F): 02/28/2020

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: 07/31/2021
• Device Model Number: RF*GA35183A
• Device Catalogue Number: GR3508
• Device Lot Number: 190830
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/05/2020
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/06/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/28/2020
• 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: STANDARD ROSCH-UCHIDA SET WITH COLAPINTO NEEDLE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Date Report Sent to FDA: 02/28/2020