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

Model Number	86702
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Cardiac Tamponade (2226); 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, blood loss & cardiac tamponade.During a redo pulmonary vein isolation procedure, a dynamic tip steerable diagnostic catheter was selected for use.Scar tissue at the anterior wall of the patient was observed, therefore, ablation on the anterior mitral line (right superior pulmonary vein to anterior mitral annulus) was performed.To check if the line was completely isolated, the physician placed the 10 pole dynamic tip catheter (used as coronary sinus catheter before) in the left atrial appendage (laa) and went for paced mapping.Pace was done from the most distal electrode pair (cs 1/2).A gap was noticed; therefore, this area was re-ablated and went for the second re-map (the dynamic tip catheter stayed in the laa during re-ablation).The physician wanted to map again under distal pacing from the diagnostic catheter, but suddenly, there was no capture.Another electrode pair (cs 7/8) was chosen, and re-map was performed.As all ablation sites were isolated the procedure was finished and the patient got a pressure bandage and was sent to the observation unit.After 20 minutes, the lab was called again and told that the patient shows signs of a pericardial tamponade.Patient developed a cardiac tamponade and lost blood.The patient was then brought back into the lab and a pericardial puncture and drainage was performed.The physician believes the dynamic tip punctured the laa wall.The patient is expected to fully recover.The device is not expected to be returned as the complication emerged after the procedure, when the device would have been discarded.

• Brand Name: DYNAMIC TIP 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 (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: 19080908
• Report Number: 2124215-2024-21850
• Device Sequence Number: 6030051
• Product Code: DRF
• UDI-Device Identifier: 08714729879848
• UDI-Public: 08714729879848
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K912213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/10/2024

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: 86702
• Device Catalogue Number: 86702
• 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: 04/10/2024
• 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: Required Intervention
• Patient Sex: Unknown