MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY INC. TORFLEX TRANSSEPTAL GUIDING SHEATH; INTRODUCER, CATHETER

Model Number	TF85-32-63-45
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Heart Block (4444)
Date of Event	07/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There is no reasonable evidence to suggest that the baylis medical devices caused or contributed to the reported incident.However, as baylis medical devices were reported to be among the devices used in the procedure, baylis medical has decided to submit this report.Dhr review was completed for the lot in question and all the devices fulfilled all requirements prior to release.
Event or Problem Description
A case of heart block requiring intervention during a left atrial appendage closure (laac) procedure was reported where the baylis medical nrg transseptal kit was used for transseptal puncture.As reported, the right bundle was inadvertently knocked while maneuvering the transseptal system, causing the patient to go into heart block.Cardiopulmonary resuscitation and external pacing were performed.The patient was stabilized and the laac procedure was successfully completed.There is no reasonable evidence to suggest that the baylis medical devices caused or contributed to the reported incident.However, as baylis medical devices were reported to be among the devices used in the procedure, baylis medical has decided to submit this report.A separate problem report has been submitted for the nrg transseptal needle with the report number 3019751610-2022-00033.

• Brand Name: TORFLEX TRANSSEPTAL GUIDING SHEATH
• Common Device Name: INTRODUCER, CATHETER
• 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: 15341239
• Report Number: 3019751610-2022-00028
• Device Sequence Number: 5231453
• Product Code: DYB
• UDI-Device Identifier: 00685447005391
• UDI-Public: (01)00685447005391(17)240302(10)TFB010322
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K183655
• 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: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 09/01/2022

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: TF85-32-63-45
• Device Lot Number: TFFB010322
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2022
• Initial Report FDA Received Date: 09/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2022
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown