MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY INC. EXPANSURE LARGE ACCESS TRANSSEPTAL DILATOR; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number	ESD125-35-67-70-N
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	06/17/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As a baylis medical device was reported to be among the devices used in the procedure, baylis medical has decided to submit this report.Device malfunction is not suspected.A dhr review has been completed for the lot in question and all devices in the lot met relevant requirements prior to release.
Event or Problem Description
The versacross rf wire and the versacross transseptal sheath were used for transseptal puncture during a cryo ablation procedure.Upon successful transseptal puncture, the physician exchanged the versacross transseptal sheath with the cryo sheath and dilator.The physician attempted to dilate the septum further using the cryo dilator but the cryo sheath was unable to cross.The cryo sheath and dilator were removed and the expansure large access transseptal dilator was used in an attempt to further dilate the septum.The cryo sheath and dilator were attempted again but was again unsuccessful.During preparation for a second transseptal puncture, the devices were removed from the left atrium and a drop of pressure was observed.A pericardial effusion was observed on fluoroscopy and a pericardial effusion tap protocol was initiated.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 mdr problem report has been submitted for the versacross rf wire and versacross transseptal sheath under mfr report number: 3019751610-2022-00015 and 3019751610-2022-00014.

• Brand Name: EXPANSURE LARGE ACCESS TRANSSEPTAL DILATOR
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• 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: 15031432
• Report Number: 3019751610-2022-00013
• Device Sequence Number: 6230612
• Product Code: DRE
• UDI-Device Identifier: 00685447004691
• UDI-Public: (01)00685447004691(17)230417(10)ESFC220121
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K201288
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/15/2022

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 Expiration Date: 04/17/2023
• Device Model Number: ESD125-35-67-70-N
• Device Lot Number: ESFC220121
• 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: 06/17/2022
• Initial Report FDA Received Date: 07/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2021
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown