MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAMIC XT STEERABLE DIAGNOSTIC CATHETER; 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 Code	Cardiac Tamponade (2226)
Date of Event	02/09/2024
Type of Reportable Event	Death
Event or Problem Description
It was reported that patient death occurred following a procedure while using two intellamap orion catheters and a dynamic xt steerable diagnostic catheter.During mapping and ablation procedure to treat a left accessory pathway arrythmia, the intellamap orion catheter was noted to be hard to manipulate because it was bent.The physician replaced the first orion because the catheter was not reacted properly to maneuvers.The issue was resolved with the second catheter.The dynamic xt steerable diagnostic catheter was placed in the coronary sinus (cs).While the physician was manipulating the orion catheter in between the aorta and the left ventricle the patient felt pain, the physician realized they suffered a left ventricle cardiac tamponade.It was unknown if the tamponade was caused by the first or second orion catheter.The tamponade occurred prior to ablation; no ablation catheter was used.Pericardiocentesis was performed.Intracardiac echocardiography (ice) imaging was performed to attempt to locate a suspected perforation.The procedure was not completed.The patient died the following day.The cause of death was related to the tamponade.No further information on patient complication were provided.The device is expected to be returned.
Additional Manufacturer Narrative
The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

• Brand Name: DYNAMIC XT STEERABLE DIAGNOSTIC CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): 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: 18788394
• Report Number: 2124215-2024-11505
• Device Sequence Number: 8255735
• Product Code: DRF
• UDI-Device Identifier: 08714729877615
• UDI-Public: 08714729877615
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K921872
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/27/2024

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: 86706
• Device Catalogue Number: 86706
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/22/2024
• Initial Report FDA Received Date: 02/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Death
• Patient Sex: Unknown