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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemoptysis (1887); Great Vessel Perforation (2152); Discomfort (2330)
Date of Event	11/05/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the radifocus glidewire advantage was used during the procedure.Following a successful sensor implant, the patient had hemoptysis and some discomfort.On november 13th, the patient still had not been discharged from the hospital due to persistent hemoptysis.The patient recovered and was discharged.The physician believes that either the non-abbott guidewire or the delivery catheter may have perforated a small part of the pulmonary anatomy.The patient's condition was stable.Additional information was received on 01feb2021.The procedure was to place a cardiomems sensor in one of the pulmonary arteries.Additional information was received on (b)(6) 2021.The doctor alleged that the terumo gwa product - ga1830, could have contributed to issue the patient developed.The physician was not certain if the wire caused the perforation or if it was the delivery system of the cardiomems device.The doctor was not ready to blame this on the wire.The patient event date regarding the sensor implant was (b)(6) 2020 and the patient remained hospitalized on (b)(6) 2020, per the report.The patient had two bronchoscopies performed to remove clot from the airway during the patient extended hospitalization.The doctor alleged that the terumo ga1830 "may have perforated small part of pulmonary anatomy"; however, there was no testing performed to confirm this condition; the patient presented with hemoptysis.The patient recovered and was discharged from the hospital on (b)(6) 2020.The additional equipment or devices used for the initial procedure of sensor implant was the wire, delivery catheter for the cardiomems, and the actual sensor.

• Brand Name: RADIFOCUS GLIDEWIRE ADVANTAGE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 11292459
• Report Number: 2243441-2021-00005
• Device Sequence Number: 19763163
• Product Code: DQX
• UDI-Device Identifier: 04987350714763
• UDI-Public: 04987350714763
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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
• Type of Report: Initial
• Report Date (Section B): 02/08/2021
• Report Date (Section F): 02/08/2021

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 Model Number: N/A
• Device Catalogue Number: GA1830
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/20/2021
• Event Location: Hospital
• Date Report to Manufacturer: 01/22/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/08/2021
• 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: Hospitalization; Other
• Patient Weight: 82
• Date Report Sent to FDA: 02/08/2021