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

Model Number RFP-100A

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/18/2022

Event Type  malfunction  

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.

Event 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 an alert occurred and resulted in the use of an alternate method for transseptal puncture.While there was no patient injury reported, baylis medical company inc.Has decided to report this event due to the 20-minute procedural delay.

• Brand Name: BAYLIS MEDICAL COMPANY RADIOFREQUENCY PUNCTURE GENERATOR
• Type of Device: 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: 16023251
• MDR Text Key: 308210864
• Report Number: 3019751610-2022-00073
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122278
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RFP-100A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/15/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other