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

Model Number	87069
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Tamponade (2226); Cardiac Perforation (2513)
Date of Event	10/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that following a concomitant procedure to treat atrial fibrillation using ablation and to implant a left atrial appendage device the patient developed cardiac tamponade.An intellanav st ablation catheter was used to perform radio frequency ablations during the procedure.Approximately twenty minutes after the procedure had been completed tamponade was identified while the patient was in the recovery room.Pericardiocentesis was performed and the patient was then moved to an operating room for surgery.A perforation inferior to the left inferior pulmonary vein (lipv) was found during the surgery.They were given blood and admitted to the hospital following the surgery for recovery.They were subsequently discharged from the hospital and expected to make a full recovery.
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.

• 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: angela hinkley ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 20516609
• Report Number: 2124215-2024-66323
• Device Sequence Number: 21007886
• Product Code: LPB
• UDI-Device Identifier: 08714729963974
• UDI-Public: 08714729963974
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/23/2024

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 Model Number: 87069
• Device Catalogue Number: 87069
• Device Lot Number: 0033800844
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2024
• Initial Report FDA Received Date: 10/23/2024
• Date Device Manufactured: 04/10/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FARAWAVE PFA CATHETER; WATCHMAN LEFT ATRIAL APPENDAGE DEVICE
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown