MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA HEARTRAIL III GUIDING CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	09/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that a dissection of the right coronary artery (rca) occurred.After three stents were deployed, the dissection occurred.The patient was hemodynamically stable and transferred to the or (operating room) for cabg (coronary artery bypass graft).The original intended procedure was a percutaneous coronary intervention of the right coronary artery.The stent(s) used were, 3.0 mm x 48 mm boston scientific synergy des, 3.0 mm x 12 mm boston scientific synergy des, and 3.0 mm x 8 mm boston scientific synergy des.An intracoronary vascular ultrasound of the rca was performed.The device did not work properly (e.G., broke, could not get it to work or stopped working).

• Brand Name: HEARTRAIL III GUIDING CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 18799043
• Report Number: 2243441-2023-00060
• Device Sequence Number: 7143670
• Product Code: DQO
• UDI-Device Identifier: 04987350383259
• UDI-Public: 04987350383259
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/26/2024
• Report Date (Section F): 02/28/2024

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: 02/28/2026
• Device Model Number: N/A
• Device Lot Number: 230323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/19/2023
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/24/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/28/2024
• 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: Required Intervention; Other
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 48 KG
• Patient Race: White
• Date Report Sent to FDA: 02/28/2024