MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY INC. VERSACROSS LARGE ACCESS TRANSEPTAL 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	Pericardial Effusion (3271)
Date of Event	06/07/2022
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.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
A case of a pericardial effusion requiring intervention was reported during a left-atrial appendage closure (laac) procedure, where the versacross large access transeptal dilator (vla) was used for the initial transseptal puncture.The vla was positioned in the superior vena cava (svc) using the j-tip guidewire.The physician exchanged the j-tip guidewire with the versacross rf wire (vxw) for transseptal puncture.While removing the j-tip guidewire, the vla slipped out of the svc into the right atrium (ra) as it was not secured and was repositioned.The vxw was advanced and transseptal was successfully completed.The vla was removed and watchman sheath (boston scientific) was advanced.The vxw was exchanged with the j-tip guidewire and a pigtail catheter was introduced over the j-tip guidewire in the left atrial appendage (laa).Dye was released and fluid around the laa was noted.A pericardial sweep was performed and an effusion was noted.The effusion continued to worsen.With the patient in stable condition, pericardiocentesis was performed.The patient was transferred to surgery approximately 30 minutes later.A 8.5-9 french hole was identified in the medial aspect of the svc at the junction of the ra.The hole was repaired.Follow-up requests revealed that the patient was recovering.As a baylis medical device was reported to be among the devices used in the procedure, baylis medical has decided to submit this report.

• Brand Name: VERSACROSS LARGE ACCESS TRANSEPTAL 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: 14940179
• Report Number: 3019751610-2022-00010
• Device Sequence Number: 6230879
• Product Code: DRE
• UDI-Device Identifier: 00685447005254
• UDI-Public: (01)00685447005254(17)240820(10)VLFA010222
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 07/06/2022

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: 08/20/2024
• Device Model Number: VLA125-35-67-D1
• Device Lot Number: VLFA010222
• 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: 06/08/2022
• Initial Report FDA Received Date: 07/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2022
• 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