MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY INC. BAYLIS MEDICAL COMPANY RADIOFREQUENCY PUNCTURE GENERATOR; RADIOFREQUENCY GENERATOR

Model Number	RFP-100A
Medical Device Problem Codes	No Apparent Adverse Event (3189); Key or Button Unresponsive/not Working (4063)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
While there was no patient injury report, baylis medical company inc.Has decided to report this event due to the procedural abortion.A dhr review was completed and the device fulfilled all requirements prior to release.
Event or Problem Description
A procedural abortion was reported in a case where the baylis radiofrequency puncture generator (rf generator) was unable to be used for a transseptal procedure.Prior to the start of the procedure the rf generator was connected, and an error was produced.The generator was restarted, however the error persisted.Another means of transseptal was not considered and the procedure was aborted.While there was no patient injury report, baylis medical company inc.Has decided to report this event due to the procedural abortion.

• Brand Name: BAYLIS MEDICAL COMPANY RADIOFREQUENCY PUNCTURE GENERATOR
• Common Device Name: RADIOFREQUENCY GENERATOR
• Manufacturer (Section D): BAYLIS MEDICAL COMPANY INC.; 5959 trans-canada highway; montreal, quebec H4T 1 A1; CA H4T 1A1
• Manufacturer (Section G): BAYLIS MEDICAL COMPANY INC.; 2775 matheson blvd. east; mississauga, ontario L4W 4 P7; CA L4W 4P7
• Manufacturer Contact: meghal khakhar ; 2775 matheson blvd east; mississauga, ontario L4W 4-P7 ; CA L4W 4P7
• MDR Report Key: 15969102
• Report Number: 3019751610-2022-00063
• Device Sequence Number: 20251039
• Product Code: GEI
• UDI-Device Identifier: 00685447000969
• UDI-Public: (01)00685447000969
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Company Representative,Distributor
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 12/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: RFP-100A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2022
• Initial Report FDA Received Date: 12/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/10/2021
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown