MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAMIC XT; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	86706
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226)
Date of Event	07/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based upon analysis of all available information, bsc's investigation found no evidence to indicate that the cardiac tamponade was related to product performance of the dynamic xt.There was no report of any device performance concerns.The complaint patient events reported are known potential adverse events related with the use of the device and are noted within the indications/instructions for use (ifu).Therefore, all compiled information on this investigation determines that the most probable cause is known inherent risk of device since the complaint patient events reported by the physician is known and documented in the labeling.
Event or Problem Description
It was reported that during an ablation procedure to treat atrial flutter (af) using an intellanav stablepoint open-irrigated catheter, intellamap orion high resolution mapping catheter, and a dynamic xt catheter, the patient experienced cardiac tamponade.Towards the end of the procedure the patient's blood pressure decreased.An echocardiogram was performed and showed pericardial effusion.Drainage removed 1500ml of fluid, after which the patient's blood pressure improved.Then, heparin was reversed, and blood products were given.The patient's blood pressure dropped again, and the surgeons were consulted.During the waiting period the patient's blood pressure crashed.Right ventricular collapse occurred, and surgery was initiated.The surgery was completed successfully, and the patient was moved to the intensive therapy unit for recovery.No perforation was found during surgery and the cause of the tamponade was not determined.

• Brand Name: DYNAMIC XT
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• 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: 17597233
• Report Number: 2124215-2023-43849
• Device Sequence Number: 6370032
• Product Code: DRF
• UDI-Device Identifier: 08714729877615
• UDI-Public: 08714729877615
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K921872
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/22/2023

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: 03/14/2026
• Device Model Number: 86706
• Device Catalogue Number: 86706
• Device Lot Number: 0031238223
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/27/2023
• Initial Report FDA Received Date: 08/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2023
• 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: INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER; INTELLANAV STABLEPOINT OPEN-IRRIGATED CATHETER
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown