MAUDE Adverse Event Report: BAYLIS MEDICALE CIE INC BAYLIS MEDICAL COMPANY RADIOFREQUENCY PUNCTURE GENERATOR; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	RFP-100A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)
Date of Event	03/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a pericardial effusion occurred.During an atrial fibrillation ablation procedure a radiofrequency puncture generator was used to perform a transeptal puncture.At an unspecified time during the procedure the patient became hypotensive.A pericardial effusion was suspected.The patient was transferred from the surgery center to a hospital and subsequently discharged on an unreported date.

• Brand Name: BAYLIS MEDICAL COMPANY RADIOFREQUENCY PUNCTURE GENERATOR
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): BAYLIS MEDICALE CIE INC; 5959 trans-canada highway; montreal H4T 1 A1; CA H4T 1A1
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112 5798
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 25536368
• Report Number: 2124215-2026-32364
• Device Sequence Number: 9634077
• Product Code: GEI
• UDI-Device Identifier: 00685447000969
• UDI-Public: (01)00685447000969
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K122278
• 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): 06/17/2026

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: RFP-100A
• Device Catalogue Number: RFP-100A
• Device Lot Number: 0111132322
• 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: 05/18/2026
• Initial Report FDA Received Date: 06/17/2026
• Date Device Manufactured: 01/24/2026
• Is the Device Labeled for Single Use? (Y/N): No
• 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; Hospitalization
• Patient Sex: Unknown