MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY INC. VERSACROSS ACCESS SOLUTION; INTRODUCER, CATHETER

Device Problem Positioning Problem (3009)

Patient Problem Asystole (4442)

Event Date 11/09/2023

Event Type  Injury  

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.

Event Description

It was reported that during a watchman left atrial appendage closure (laac) procedure to treat non-valvular atrial fibrillation (nvaf), a versacross large access kit was selected for use.The patient had large bi-atrial enlargement and the physician put a large bend in the versacross sheath to perform transseptal puncture.It was noted that the patient went asystolic when the sheath made in contact with atrioventricular (av) node tissue.A transcutaneous pacing was done by the anesthesiologist and the implanter physician placed a temporary pacemaker.No effusion was noted and the procedure was continued and completed successfully.The patient had normal sinus rhythm and the pacemaker was removed later.The device is not expected to be returned for analysis.It was further confirmed the versacross sheath came in contact with av node prior to transseptal puncture.The rf wire was in the versacross sheath, but not exposed.There were three attempts required to track up / drop down into position on septum before tsp but no visualizing difficulty noted.

Manufacturer Narrative

Due to information provided on 14dec2023, the fields b5 (describe event or problem), d1 (brand name), d2a (common device name), d2b (pro code (product code)) and g4 (premarket / 5109k)#), this supplemental mdr will be filed.It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.

Event Description

It was reported that during a watchman left atrial appendage closure (laac) procedure to treat non-valvular atrial fibrillation (nvaf), a versacross access kit was selected for use.The patient had large bi-atrial enlargement and the physician put a large bend in the versacross sheath to perform transseptal puncture.It was noted that the patient went asystolic when the sheath made in contact with atrioventricular (av) node tissue.A transcutaneous pacing was done by the anesthesiologist and the implanter physician placed a temporary pacemaker.No effusion was noted and the procedure was continued and completed successfully.The patient had normal sinus rhythm and the pacemaker was removed later.The device is not expected to be returned for analysis.It was further confirmed the versacross sheath came in contact with av node prior to transseptal puncture.The rf wire was in the versacross sheath, but not exposed.There were three attempts required to track up / drop down into position on septum before tsp but no visualizing difficulty noted.It was further confirmed that versacross access solution sheath was the one used in the procedure.

• Brand Name: VERSACROSS ACCESS SOLUTION
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): BAYLIS MEDICAL COMPANY INC.; 5959 trans-canada highway; montreal H4T 1 A1; CA H4T 1A1
• Manufacturer (Section G): BAYLIS MEDICAL COMPANY INC.; 5825 explorer drive; mississauga, on L4W 5 P6; CA L4W 5P6
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 18251400
• MDR Text Key: 329553566
• Report Number: 2124215-2023-66988
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/04/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2023
• 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: 12/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Race: White