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

Model Number	VSTK0121
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)
Date of Event	04/16/2025
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.
Event or Problem Description
It was reported pericardial effusion (pe) occurred.The procedure was aborted.A concomitant procedure where a left atrial appendage (laa) closure procedure and a pulse field ablation (pfa) were being performed, a versacross steerable access solution kit was selected for use.Transesophageal echocardiogram (tee) imaging was utilized.A pre-procedure effusion was noted on imaging but location and size are unknown.Heparin was given for anticoagulation intraprocedure.The transseptal puncture (tsp) was completed.The pfa was performed using farapulse pfa system.Subsequently the laa closure procedure was performed, and a watchman fxd double curve access system (was) was inserted and positioned at the laa.A 27mm watchman flx pro closure device and delivery system (wds) was advanced and deployed, yet the physician was not confident in positioning of the device, so it was recaptured and removed.Hypotension was noted while the physician exchanged the was for a watchman fxd single curve access system.The pe was analyzed, and it did not grow in size.Protamine was given to reverse the heparin, and a transthoracic echocardiogram (tte) was performed which noted the pe did not grow in size.The patient remained stable, it was hospitalized and discharged on (b)(6) 2025.The device is not expected to be returned for analysis (disposed).No issues/difficulties noted during tsp.Physician is not sure what cause the complication.Act was therapeutic.
Additional Manufacturer Narrative
The device did not return for analysis.However, the reported allegation of pericardial effusion was confirmed based on the media provided.However, the hypotension cannot be confirmed based on the media provided.Additionally, a correction to the initial mdr in block outcomes attrib to adv event (b2), in section b - adverse event/product prob.
Event or Problem Description
It was reported pericardial effusion (pe) occurred.The procedure was aborted.A concomitant procedure where a left atrial appendage (laa) closure procedure and a pulse field ablation (pfa) were being performed, a versacross steerable access solution kit was selected for use.Transesophageal echocardiogram (tee) imaging was utilized.A pre-procedure effusion was noted on imaging but location and size are unknown.Heparin was given for anticoagulation intraprocedure.The transseptal puncture (tsp) was completed.The pfa was performed using farapulse pfa system.Subsequently the laa closure procedure was performed, and a watchman fxd double curve access system (was) was inserted and positioned at the laa.A 27mm watchman flx pro closure device and delivery system (wds) was advanced and deployed, yet the physician was not confident in positioning of the device, so it was recaptured and removed.Hypotension was noted while the physician exchanged the was for a watchman fxd single curve access system.The pe was analyzed, and it did not grow in size.Protamine was given to reverse the heparin, and a transthoracic echocardiogram (tte) was performed which noted the pe did not grow in size.The patient remained stable, it was hospitalized and discharged on (b)(6) 2025.The device is not expected to be returned for analysis (disposed).No issues/difficulties noted during tsp.Physician is not sure what cause the complication.Act was therapeutic.

• Brand Name: VERSACROSS STEERABLE 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; 2775 matheson blvd east; mississauga, on L4W 4 P7; CA L4W 4P7
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 21961472
• Report Number: 2124215-2025-28600
• Device Sequence Number: 15771604
• Product Code: DXF
• UDI-Device Identifier: 00685447019701
• UDI-Public: (01)00685447019701(17)280121(10)36121688
• 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
• 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
• Report Date (Section B): 06/19/2025

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: VSTK0121
• Device Catalogue Number: VSTK0121
• Device Lot Number: 0036121688
• 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: 04/16/2025
• Supplement Date Received by Manufacturer: 05/30/2025
• Initial Report FDA Received Date: 05/05/2025
• Supplement Report FDA Received Date: 06/19/2025
• Date Device Manufactured: 01/21/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention; Hospitalization
• Patient Sex: Unknown