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

Device Problems Material Integrity Problem (2978); Positioning Problem (3009)

Patient Problems Chest Pain (1776); Dyspnea (1816); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 10/13/2023

Event Type  Injury  

Event Description

It has been reported that a versacross access solution kit has been selected for use for a watchman procedure.A pericardial effusion and cardiac tamponade were reported.During the procedure, the physician stated that versacross sheath went to an unknown location which was believed to be the left atrium, but was confirmed to not be.The physician was unaware of the sheath location at this time and was unable to locate it through transesophageal echocardiogram (tee).Post-procedure, the patient began experiencing shortness of breath and chest pain, which was confirmed through transthoracic echocardiogram (tte) to be caused by an effusion near the apex/left ventricle, followed by a cardiac tamponade.No pericardial effusion (pe) was noted prior to procedure.The implant was still deployed and the procedure was completed successfully as the effusion was discovered post-implant.A periocardiocentesis was done.The current patient status is unknown.The patient was admitted beyond standard of care.The device is not expected to be returned for analysis.It has been further mentioned that there was no issue observed with the versacross rf wire.It was required multiple attempts to track up/down into position on septum before tsp.

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.

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.This supplemental mdr has been created in response to a gfe dated 07nov2023, sections b5 (event description) and b2 (outcomes attributing to adverse event) have been updated.

Event Description

It has been reported that a versacross access solution kit has been selected for use for a watchman procedure.A pericardial effusion and cardiac tamponade were reported.During the procedure, the physician stated that versacross sheath went to an unknown location which was believed to be the left atrium, but was confirmed to not be.Multiple attempts were required to track up/down into position on septum before transseptal.The physician was unaware of the sheath location at this time and was unable to locate it through transesophageal echocardiogram (tee).Post-procedure, the patient began experiencing shortness of breath and chest pain, which was confirmed through transthoracic echocardiogram (tte) to be caused by an effusion near the apex/left ventricle, followed by a cardiac tamponade.No pericardial effusion (pe) was noted prior to procedure.The implant was still deployed and the procedure was completed successfully as the effusion was discovered post-implant.A periocardiocentesis was done.The current patient status is unknown.The patient was admitted beyond standard of care.The device is not expected to be returned for analysis.It has been further mentioned that there was no issue observed with the versacross rf wire.In addition, the effusion was successfully managed using a tapping method and the patient was safely discharged.

• 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 INC.; 5825 explorer dr.; 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: 18085035
• MDR Text Key: 327541686
• Report Number: 2124215-2023-62252
• 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: 12/05/2023

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2023
• Initial Date FDA Received: 11/07/2023
• Supplement Dates Manufacturer Received: 11/07/2023
• Supplement Dates FDA Received: 12/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization; Other
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Race: White