MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA HEARTTRAIL 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	03/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the doctor performed an interventional procedure in the proximal/mid right coronary artery (rca) and ended up dissecting the aorta near the ostia of the rca.A stent was placed to fix the dissection.The patient was stable, and the procedure was successful.The dissection happened toward the end of the case.They popped out of the ostium a few times and during one of their last times entering, the doctor mentioned he had dissected the aorta right at the ostia to the rca.Additional information was received on 08mar2023: the devices used were balloons, wires, intravascular ultrasound (ivus), and a telescoping catheter.The patient had a dissection that was covered by a stent.

• Brand Name: HEARTTRAIL 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: 18220468
• Report Number: 2243441-2023-00044
• Device Sequence Number: 5602231
• Product Code: DQO
• UDI-Device Identifier: 04987350715227
• UDI-Public: 04987350715227
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 11/28/2023
• Report Date (Section F): 11/28/2023

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: 40-5380
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/01/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/03/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/28/2023
• 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: BALLOONS; TELESCOPING CATHETER; WIRES
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 11/28/2023