MAUDE Adverse Event Report: JAPAN LIFELINE CO., LTD. CARDIAC CATHETER; CATHETER, STEERABLE

Patient Problems Perforation (2001); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 07/05/2023

Event Type  Injury  

Event Description

It was reported that the right ventricular (rv) apex was perforated by rv catheter (manufactured by jll).Pericardial drainage was performed, and the patient was transported to (b)(6) hospital (another hospital).Open chest surgery was conducted at another hospital.No cardiopulmonary bypass was used.A perforation site was sutured, and the patient was stable.Atrial septal puncture was not performed.Ablation was not performed before pericardial effusion or tamponade was confirmed.Steam pop was not confirmed.The procedure was for a paroxysmal supraventricular tachycardia.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: CARDIAC CATHETER
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): JAPAN LIFELINE CO., LTD.; 25f, 2-2-20, tennez ocean square; higashishinagawa, shinagawa-ku; tokyo 140-0 002; JA 140-0002
• MDR Report Key: 17453507
• MDR Text Key: 320415633
• Report Number: MW5120540
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1