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 Problems Cardiac Arrest (1762); Cardiac Tamponade (2226)

Event Date 07/28/2022

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 cardiac tamponade requiring intervention was reported during a left-atrial appendage closure (laac) procedure where the versacross transseptal sheath (vxs) and versacross rf wire (vxw) were used for the initial transseptal puncture.During the transseptal workflow, the physician experienced challenges visualizing tenting of the septum.Following manipulation and reintroduction of the device assembly, tenting was observed and transseptal puncture with delivery of rf energy was achieved.However, the vxw was not observed in the left atrium.A pericardial effusion was noted, and the patient's blood pressure dropped.Shortly after, cardiac tamponade occurred.Chest compressions and pericardiocentesis was completed and the patient was stabilized.An arterial line was placed and the patient was continuously monitored.Approximately 15 minutes later, the patient's blood pressure dropped again and a blood transfusion was required.The patient was admitted to the icu for recovery.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 mdr has been submitted for the versacross rf wire under mfr report number: 3019751610-2022-00024.

• 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: 15332445
• MDR Text Key: 299037096
• Report Number: 3019751610-2022-00025
• 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: 08/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2022
• 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: 08/08/2022
• 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): Hospitalization; Required Intervention; Life Threatening