MAUDE Adverse Event Report: TERUMO RADIFOCUS; WIRE, GUIDE, CATHETER

Model Number RADIFOCUS

Device Problem Connection Problem (2900)

Patient Problems Low Blood Pressure/ Hypotension (1914); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Type  Injury  

Event Description

The blood vessel was narrow and tortuous, so me wire did not insert a sub-catheter was used, but the wire did not insert.A trial and error was made for about 45 minutes; perforation was confirmed when contrast imaging was performed.Blood pressure temporarily decreased due to coronary vein perforation, and echocardiography was confirmed.Pericardia puncture was performed due to pericardial effusion.Subsequently, arterial pressure was monitored and stabilized.The physician's opinion was that it could not be judged whether it was caused by a wire or a catheter, so it was difficult to identify the cause.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: RADIFOCUS
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO
• MDR Report Key: 17533046
• MDR Text Key: 321164423
• Report Number: MW5139952
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: RADIFOCUS
• Patient Sequence Number: 1