MAUDE Adverse Event Report: BAYLIS MEDICALE CIE INC VERSACROSS CONNECT LAAC ACCESS SOLUTION; CATHETER, SEPTOSTOMY

Model Number	VXAK0003
Medical Device Problem Codes	Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	02/24/2025
Type of Reportable Event	Serious Injury
Additional 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.Good faith effort attempts are in progress to try and retrieve additional details regarding the reported event, but further information was unable to be obtained as of yet.
Event or Problem Description
A cardiac tamponade, pericardial effusion and perforation were noted.It has been reported that a versacross connect laac access solution kit was selected for use for a watchman procedure.During the procedure, the user mentioned that they had to rewire a few times to get the right transseptal.Eventually, the wire crossed the septum while tenting, no rf application performed.At this point, the patient had a slight drop in blood pressure and a circumferential effusion was noticed.The effusion was monitored, and since it did enlarge, the physician felt comfortable continuing with the procedure, which was completed successfully in one attempt with the watchman device.After releasing the device, they checked the effusion again and stated that it may have gotten larger and proceeded to perform pericardiocentesis.Upon further evaluation, it was determined that the patient had even lower blood pressure and a slight cardiac tamponade.In addition, the physician believes that the ice catheter may have caused a perforation.Patient was sent for additional surgery and is expected to fully recover.Product is not expected to return for analysis (disposed).No pericardial effusion was noted prior to the procedure.The patient was not under warfarin nor antiplatelet drugs at the time.
Event or Problem Description
A cardiac tamponade, pericardial effusion and perforation were noted.It has been reported that a versacross connect laac access solution kit was selected for use for a watchman procedure.During the procedure, the user mentioned that they had to rewire a few times to get the right transseptal.Eventually, the wire crossed the septum while tenting, no rf application performed.At this point, the patient had a slight drop in blood pressure and a circumferential effusion was noticed.The effusion was monitored, and since it did enlarge, the physician felt comfortable continuing with the procedure, which was completed successfully in one attempt with the watchman device.After releasing the device, they checked the effusion again and stated that it may have gotten larger and proceeded to perform pericardiocentesis.Upon further evaluation, it was determined that the patient had even lower blood pressure and a slight cardiac tamponade.In addition, the physician believes that the ice catheter may have caused a perforation.Patient was sent for additional surgery and is expected to fully recover.Product is not expected to return for analysis (disposed).No pericardial effusion was noted prior to the procedure.The patient was not under warfarin nor antiplatelet drugs at the time.It was further reported that the patient was successfully discharged on (b)(6) 2025.In the physician's opinion, the device did not contribute to the adverse event.The act was therapeutic.No other issues were reported.
Additional Manufacturer Narrative
Due to additional information received, this report is being submitted for the update on the field describe event or problem (b5), in section b - adverse event/product prob.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.We are unable to provide the complete unique identifier (udi) at the time of the submission of this report, as it was not yet available.If additional details become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Correction to the follow-up 1 mdr in block(s) device codes (f10 and h6), in sections f - for use by uf/importer and h - device manufacturers only.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.We are unable to provide the complete unique identifier (udi) at the time of the submission of this report, as it was not yet available.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
A cardiac tamponade, pericardial effusion and perforation were noted.It has been reported that a versacross connect laac access solution kit was selected for use for a watchman procedure.During the procedure, the user mentioned that they had to rewire a few times to get the right transseptal.Eventually, the wire crossed the septum while tenting, no rf application performed.At this point, the patient had a slight drop in blood pressure and a circumferential effusion was noticed.The effusion was monitored, and since it did enlarge, the physician felt comfortable continuing with the procedure, which was completed successfully in one attempt with the watchman device.After releasing the device, they checked the effusion again and stated that it may have gotten larger and proceeded to perform pericardiocentesis.Upon further evaluation, it was determined that the patient had even lower blood pressure and a slight cardiac tamponade.In addition, the physician believes that the ice catheter may have caused a perforation.Patient was sent for additional surgery and is expected to fully recover.Product is not expected to return for analysis (disposed).No pericardial effusion was noted prior to the procedure.The patient was not under warfarin nor antiplatelet drugs at the time.It was further reported that the patient was successfully discharged on (b)(6) 2025.In the physician's opinion, the device did not contribute to the adverse event.The act was therapeutic.No other issues were reported.

• Brand Name: VERSACROSS CONNECT LAAC ACCESS SOLUTION
• Common Device Name: CATHETER, SEPTOSTOMY
• Manufacturer (Section D): BAYLIS MEDICALE CIE INC; 5959 trans-canada highway; montreal H4T 1 A1; CA H4T 1A1
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; zona franca la lima; cartgo, 03 30106 ; CS 30106
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 21632508
• Report Number: 2124215-2025-16472
• Device Sequence Number: 21143758
• Product Code: DXF
• UDI-Device Identifier: 00685447018346
• UDI-Public: (01)00685447018346
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K150709
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/29/2025

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
• Operator of Device: Health Professional
• Device Model Number: VXAK0003
• Device Catalogue Number: VXAK0003
• Device Lot Number: 0035007983
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2025
• Supplement Date Received by Manufacturer: 03/05/2025; 04/29/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 03/31/2025; 04/29/2025
• Date Device Manufactured: 04/24/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown