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

Model Number	RFP-100A
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A 20- minute procedural delay was reported in a case where the baylis radiofrequency puncture generator (rf generator) was unable to be used for a transseptal procedure.During a cardiology procedure, the rf generator was attempted to be used to provide rf energy to the transseptal device.A 20-minute procedural delay due to issues with a button on the generator was reported and an alternate method for transseptal puncture was used for the procedure.While there was no patient injury report, baylis medical company inc.Has decided to report this event due to the 20-minute procedural delay.
Additional Manufacturer Narrative
While there was no patient injury report, baylis medical company inc.Has decided to report this event due to the 20-minute procedural delay.A dhr review was completed and the device fulfilled all requirements prior to release.

• 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: 15974238
• Report Number: 3019751610-2022-00065
• Device Sequence Number: 5896633
• Product Code: GEI
• UDI-Device Identifier: 00685447000969
• UDI-Public: (01)00685447000969
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Initial Reporter Occupation: Other Health Care Professional
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2022
• Initial Report FDA Received Date: 12/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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