MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION BLAZER DX-20; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	M00420SL21020
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Tachycardia (2095); Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	10/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information, but it was not available because the device was disposed.Because the product is unknown, we are unable to provide the unique identifier (udi) and other specific product information.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.
Event or Problem Description
It was reported that the patient experienced pericardial effusion.A blazer dx-20 catheter was used during an atrial fibrillation (af) procedure.During the procedure, a non-sustained atrial tachycardia was observed in the lateral wall of the right atrium.An intellamap orion catheter was utilized to map the patient's cardiac activity.The physician suspects that the diagnostic catheter may have pushed too hard causing a small perforation near the tip of the lateral annulus during the tachycardia episode.No medical or surgical intervention was performed, as the physician is confident that the complication will resolve spontaneously.The issue was resolved, and the procedure was completed with this device, the ablation workflow was normal and not prolonged.The patient remains admitted for monitoring and is expected to recover.The next day, the patient was discharged.The device will not be returned for analysis, as it was disposed of by the facility.

• Brand Name: BLAZER DX-20
• 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: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 23476668
• Report Number: 2124215-2025-78758
• Device Sequence Number: 10228665
• Product Code: DRF
• UDI-Device Identifier: 08714729780526
• UDI-Public: (01)08714729780526
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K211375
• 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): 11/05/2025

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: M00420SL21020
• Device Catalogue Number: M00420SL21020
• 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: 10/07/2025
• Initial Report FDA Received Date: 11/05/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown