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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Air Embolism (1697)

Event Date 04/19/2022

Event Type  Injury  

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.

Event Description

A case of air embolism requiring intervention was reported during a left atrial appendage closure (laac) procedure where the versacross transseptal sheath and versacross rf wire were used for the initial transeptal puncture.Transseptal puncture was successfully completed and the versacross transseptal sheath was removed from the patient with the versacross rf wire maintaining transseptal access.The watchman sheath/dilator (boston scientific corporation) was being advanced over the versacross rf wire to the left atrium when an anomaly was noted in the left atrial appendage on transesophageal echocardiogram.The watchman sheath/dilator was removed.The physician attempted to aspirate the air unsuccessfully.The procedure continued with the watchman devices.The laac procedure was later aborted due to patient anatomy.The patient is reported to be fully recovered.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 versacross rf wire with mdr report number 9710452-2022-00044.

• Brand Name: VERSACROSS TRANSSEPTAL SHEATH
• Type of Device: 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: 14465819
• MDR Text Key: 294767083
• Report Number: 9710452-2022-00045
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183655
• 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: 05/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention