MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION; CARDIAC ABLATION PERCUTANEOUS CATHETER

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

Patient Problems Chest Pain (1776); Pericardial Effusion (3271)

Event Date 11/16/2023

Event Type  Injury  

Manufacturer Narrative

There is no indication that the device will be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.

Event Description

It was reported that a non-bonton scientific clinical study ventricular tachycardia (vt) ablation procedure was performed involving an unspecified boston scientific diagnostic catheter.It was reported that the patient presented with a new onset of chest discomfort early morning post vt ablation procedure.Transesophageal echocardiography (tee) reveled that a pericardial effusion is now more clearly circumferential, larger than yesterday.Small right ventricle with hemodynamic effects from the pericardial effusion was worse compared to yesterday.Pericardiocentesis was performed.It was reported that the event was due to the rv diagnostic catheter because it was left it in the inferior wall with vt, it perforated, but flexibility was fine.No tamponade was noted initially the next day.

• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 18285086
• MDR Text Key: 329961763
• Report Number: 2124215-2023-69501
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Required Intervention