MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA HEARTRAIL 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 09/14/2023

Event Type  Injury  

Event 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
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 18799043
• MDR Text Key: 336459431
• Report Number: 2243441-2023-00060
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/28/2024,02/26/2024

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
• Device Operator: Health Professional
• 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
• Date Report Sent to FDA: 02/28/2024
• Distributor Facility Aware Date: 10/19/2023
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/24/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/28/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 48 KG
• Patient Race: White