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

Model Number	87069
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Codes	Chest Pain (1776); Dyspnea (1816); Pericardial Effusion (3271)
Date of Event	04/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced a pericardial effusion.During an ablation procedure to treat an av node reentry tachycardia (avnrt) in the accessory pathway, an intellanav st ablation catheter was selected for use.While mapping in the left atrium with the intellanavst catheter, the patient experienced chest discomfort and difficulty breathing.The physician checked the x-ray and saw that the cardiac silhouette was not moving as it should.The echo, operating room (or) and anesthesia teams were called into the procedure laboratory.It was confirmed that there was a moderate effusion.Pericardiocentesis procedure drew off approximately 500cc of blood.The patient was stable, but the procedure was aborted.Also, it was noted that the ablation catheter did not seem to behave as normal.The catheter is not expected to be returned as it was disposed.
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.

• Brand Name: INTELLANAV ST ABLATION CATHETER
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 19164698
• Report Number: 2124215-2024-24256
• Device Sequence Number: 18106795
• Product Code: LPB
• UDI-Device Identifier: 08714729963950
• UDI-Public: 08714729963950
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P920047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/23/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/13/2025
• Device Model Number: 87069
• Device Catalogue Number: 87069
• Device Lot Number: 0030348962
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/02/2024
• Initial Report FDA Received Date: 04/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown