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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vascular Dissection (3160)

Event Date 03/01/2023

Event Type  Injury  

Event 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
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 18220468
• MDR Text Key: 329157626
• Report Number: 2243441-2023-00044
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 04987350715227
• UDI-Public: 04987350715227
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Report Sent to FDA: 11/28/2023
• Distributor Facility Aware Date: 03/01/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/03/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BALLOONS; TELESCOPING CATHETER; WIRES
• Patient Outcome(s): Required Intervention; Other