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

Model Number VST85-35-BD-71M-D1

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

Patient Problem Pericardial Effusion (3271)

Event Date 09/22/2022

Event Type  Injury  

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.

Event Description

A case of pericardial effusion requiring intervention was reported where the baylis medical versacross transseptal sheath (vxs), versacross steerable sheath (vst) and two versacross rf wires (vxw) were used during a left atrial appendage closure (laac) procedure.During the transseptal workflow, the patient was noted to have complex patient anatomy making the positioning of the devices on the septum challenging.The vxs was positioned on the septum and transseptal puncture was successfully completed the with the first vxw.Difficulty was experienced when trying to advance the vxs through the transseptal puncture site.Contrast was administered and a posterior/inferior pericardial effusion was noted.The procedure was paused.The patient's hemodynamics remained unchanged, and all contrast cleared the pericardial space after approximately 15 minutes.The procedure continued.The vxs and first vxw were exchanged for the vst and a second vxw.The physician experienced difficulty positioning the vst on the septum.Multiple attempts were made to reposition the devices and complete the transseptal puncture with the vst and vxw without success.During this time the patient's blood pressure began to drop and a posterior effusion was noted.Pericardiocentesis was initiated and the patient was stabilized.The laac procedure was aborted, and the patient was kept for overnight observation.As baylis medical devices were reported to be among the devices used in the procedure, baylis medical has decided to submit this report.Separate problem reports have been submitted for the versacross transseptal sheath, first versacross rf wire and second versacross rf wire with mdr report numbers 3019751610-2022-00039, 3019751610-2022-00041, and 3019751610-2022-00047 respectively.

• Brand Name: VERSACROSS STEERABLE 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: 15669969
• MDR Text Key: 302398910
• Report Number: 3019751610-2022-00040
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190688
• 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: 10/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: VST85-35-BD-71M-D1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization