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

Model Number	GA1830
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemoptysis (1887)
Date of Event	10/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Terumo medical received a letter from abbott, abbott per-2024-0167633, in regard to an adverse event.The description states: "the report was concerning the.018" x 300 cm glidewire advantage manufactured by terumo.It was reported that a cardiomems implant procedure was abandoned due to hemoptysis.During a cardiomems implant procedure, the cardiomems delivery catheter was advanced over an 0.018" x 300 cm glidewire advantage.Before the delivery catheter entered the right ventricular outflow tract (rvot), the patient began to cough and was found to have blood in their mouth.The procedure was then abandoned due to hemoptysis.The abbott rep confirmed that no interventions were needed to stop the hemoptysis and fluoroscopy during the procedure was performed to identify potential causes.The physician felt that the cause of the hemoptysis was damage to the distal pulmonary artery caused by the glidewire advantage.The patient was admitted to the intense care unit (icu).After the procedure for monitoring and released on (b)(6) 2024.The procedure perfromed was cardiomems implant.

• Brand Name: GLIDEWIRE ADVANTAGE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya, shizuok 418-0 015; JA 418-0015
• MDR Report Key: 21537811
• Report Number: 2243441-2025-00010
• Device Sequence Number: 12546269
• Product Code: DQX
• UDI-Device Identifier: 04987350714763
• UDI-Public: (01)04987350714763
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 03/06/2025
• Report Date (Section F): 03/06/2025

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: GA1830
• Device Catalogue Number: RA*FA18301C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/25/2025
• Event Location: Hospital
• Date Report to Manufacturer: 02/26/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/06/2025
• 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: DELIVERY CATHETER
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 03/06/2025