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

Model Number	VLA125-35-67-D1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	10/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There is no evidence to suggest that the baylis medical devices caused or contributed to the reported incident.However, as a baylis medical devices were reported to be among the devices used in the procedure, baylis medical has decided to submit this report.There is no suspected device malfunction.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 cardiac tamponade occurred during a cryoablation procedure, where the versacross rf wire and versacross large access dilator were used along other devices.The right atrial wall was punctured inadvertently while attempting transseptal puncture multiple times due to poor imaging with the intracardiac echocardiography (ice) catheter.The patient developed an effusion leading to cardiac tamponade.Chest compression and cpr was performed, followed by pericardiocentesis.Transesophageal echocardiography (tee) was conducted to check for cardiac structures.There was no left or right atrial compression noted.The procedure was aborted after approximately 2-hour delay.The patient was announced to be in a stable condition; however, hypoxia was noted.The patient started crashing again.Chest compression and cpr was performed.There is no evidence to suggest that the baylis medical devices caused or contributed to the reported incident.However, as a 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 versacross rf wire with mdr report number 9710452-2021-00053.

• Brand Name: VERSACROSS LARGE ACCESS TRANSSEPTAL DILATOR
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• 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: 12803609
• Report Number: 9710452-2021-00054
• Device Sequence Number: 5548343
• Product Code: DRE
• UDI-Device Identifier: 00685447005254
• UDI-Public: (01)00685447005254(17)240302(10)VLFB060721
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/12/2021

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: 03/02/2024
• Device Model Number: VLA125-35-67-D1
• Device Lot Number: VLFB060721
• 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: 10/20/2021
• Initial Report FDA Received Date: 11/12/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2021
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Sex: Unknown