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

Model Number	VXAK0007
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Device Sensing Problem (2917); Positioning Problem (3009)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	04/17/2025
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.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information, but it was not available because device was discarded.Because the product is unknown, we are unable to provide the unique identifier (udi) and other specific product information.
Event or Problem Description
It was reported that a pericardial effusion (pe) occurred.During a watchman procedure, a versacross connect laac kit was selected for use.The physician gained access to vein and then advanced the wire up to the superior vena cava (svc).The sheath was then advanced up to the svc.Then, the physician dropped down on to the fossa, however the tenting was not seen.The physician advanced the wire up to the svc however it was noted they were inferior and mid on short axis but it was suspected that they were too inferior and the rf wire went through the right atrium.The patient pressure dropped and around a centimeter effusion noted.A 400 cc blood was aspirated and then infused back in.The patient was stable and hence the physician proceeded with a 35 mm watchman device was released.There was no effusion at end of procedure.Echo was repeated and no effusion was seen.The patient was expected to fully recover, stayed one day at the hospital and has been discharged.The device is not expected to be returned for analysis (disposed).Difficult anatomy heart rotated was reported.It was not possible to see the tent well on tee in 90 view which shows ivc svc.Drained the fluid once blood stopped accumulating, and we finished the procedure.Act therapeutic during the procedure.
Additional Manufacturer Narrative
This report was amended to update international medical device regulators forum (imdrf) codes.Incomplete coding of this event was identified during a retrospective review of complaints associated with capa-8580, which focused on identifying and remediating incomplete coding of events.Investigation summary based on the available information, although the product was disposed of and could not be returned, we have determined that the trial perforation, pericardial effusion, major hemorrhage and hypotension are known inherent risk of use of this device.Device history record review: the lot number was not provided; therefore, a ship history of previous lots sent to the customer were reviewed.The manufacturing batch record review confirmed that the devices met all material, assembly, and performance specifications." device technical analysis it was indicated that the device was disposed; therefore, a technical analysis of the complaint device could not be completed.Labeling review based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications/instructions for use (ifu).Risk review: a risk review performed for the device confirmed that the events of wrong rf tip positioning (due to inadequate imaging technique or not using proximal markers) leads to rf delivery to undesired tissue is captured in the rfw hazard analysis, with the and the harm pericardial effusion.These are known events defined in the product risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Product risk benefit includes consideration of risk severity and rate, and the overall residual risk of the device is acceptable.Investigation conclusion the device has not been returned to bsc for analysis, and the information within the event description and through a label review, it suggests that the clinical events including, pericardial effusion and hemorrhage are anticipated in nature as per the ifu as reported to bsc.There are several factors that may have contributed to the allegation such as incorrect puncture location, misinterpretation of imaging information resulting in sub-optimal puncture location, physician/scrub tech technique, difficult patient anatomy (rotated heart).Based information in the event description provided, the allegation of adverse events are confirmed and are listed within the ifu, therefore known inherent risks of device.
Event or Problem Description
It was reported that a pericardial effusion (pe) occurred.During a watchman procedure, a versacross connect laac kit was selected for use.The physician gained access to vein and then advanced the wire up to the superior vena cava (svc).The sheath was then advanced up to the svc.Then, the physician dropped down on to the fossa, however the tenting was not seen.The physician advanced the wire up to the svc however it was noted they were inferior and mid on short axis but it was suspected that they were too inferior and the rf wire went through the right atrium.The patient pressure dropped and around a centimeter effusion noted.A 400 cc blood was aspirated and then infused back in.The patient was stable and hence the physician proceeded with a 35 mm watchman device was released.There was no effusion at end of procedure.Echo was repeated and no effusion was seen.The patient was expected to fully recover, stayed one day at the hospital and has been discharged.The device is not expected to be returned for analysis (disposed).Difficult anatomy heart rotated was reported.It was not possible to see the tent well on tee in 90 view which shows ivc svc.Drained the fluid once blood stopped accumulating, and we finished the procedure.Act therapeutic during the procedure.
Event or Problem Description
It was reported that a pericardial effusion (pe) occurred.During a watchman procedure, a versacross connect laac kit was selected for use.The physician gained access to vein and then advanced the wire up to the superior vena cava (svc).The sheath was then advanced up to the svc.Then, the physician dropped down on to the fossa, however the tenting was not seen.The physician advanced the wire up to the svc however it was noted they were inferior and mid on short axis but it was suspected that they were too inferior and the rf wire went through the right atrium.The patient pressure dropped and around a centimeter effusion noted.A 400 cc blood was aspirated and then infused back in.The patient was stable and hence the physician proceeded with a 35 mm watchman device was released.There was no effusion at end of procedure.Echo was repeated and no effusion was seen.The patient was expected to fully recover, stayed one day at the hospital and has been discharged.The device is not expected to be returned for analysis (disposed).Difficult anatomy heart rotated was reported.It was not possible to see the tent well on tee in 90 view which shows ivc svc.Drained the fluid once blood stopped accumulating, and we finished the procedure.Act therapeutic during the procedure.
Additional Manufacturer Narrative
Investigation summary based on the available information, although the product was disposed of and could not be returned, we have determined that the atrial perforation, pericardial effusion, major hemorrhage and hypotension are known inherent risk of use of this device.Device history record review: the lot number was not provided; therefore, a ship history of previous lots sent to the customer were reviewed.The manufacturing batch record review confirmed that the devices met all material, assembly, and performance specifications.Device technical analysis it was indicated that the device was disposed; therefore, a technical analysis of the complaint device could not be completed.Labeling review review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Risk review: a risk review performed for the device confirmed that the events of wrong rf tip positioning (due to inadequate imaging technique or not using proximal markers) leads to rf delivery to undesired tissue is captured in the device hazard analysis, with the harm pericardial effusion, cardiac trauma, hemorrhage and hypotension.These are known events defined in the product risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Product risk benefit includes consideration of risk severity and rate, and the overall residual risk of the device is acceptable.Investigation conclusion based on the information provided, boston scientific has selected the investigation conclusion code of known inherent risk of device, as the label review suggests that the clinical events including perforation and/or tamponade, hemorrhage, and pericardial/pleural effusion are anticipated in nature as per the ifu as reported to bsc.There are several factors that may have contributed to the allegation such as incorrect puncture location, misinterpretation of imaging information resulting in sub-optimal puncture location, physician/scrub tech technique, difficult patient anatomy (rotated heart).Based information in the event description provided, the allegation of adverse events are confirmed and are listed within the ifu, therefore known inherent risks of device.

• 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): BAYLIS MEDICAL COMPANY INC.; 5825 explorer drive; mississauga, on; mississauga, on L4W 5 P6; CA L4W 5P6
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 21977557
• Report Number: 2124215-2025-29322
• Device Sequence Number: 9274140
• Product Code: DXF
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K150709
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/21/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: VXAK0007
• Device Catalogue Number: VXAK0007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2025
• Supplement Date Received by Manufacturer: 04/02/2026; 04/28/2026
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 04/21/2026; 05/21/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Race: White