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

Lot Number	0033555702
Medical Device Problem Code	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	06/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a perforation, pericardial effusion (pe) and cardiac tamponade occurred; procedure was cancelled.During a watchman left atrial appendage closure (laac) procedure, a versacross connect access solution kit was selected for use.The physician was able to successfully cross the interatrial septum (ias) with the versacross rf pigtail wire with no issues (inferior and mid/posterior).However, since the patients ias was thick, it caused the versacross dilator and watchman sheath to get hung up.In an attempt to cross and dilate it, the physician increased his forward pressure on the ias with the devices, and they both suddenly and unexpectedly advanced through the ias, which lead to the dilator went too far into the left atrium (la) and perforated the posterior wall of the la.The tip of the versacross rf wire was protruding out of the dilator at this time.A pericardial effusion was immediately noticed via transesophageal echocardiogram (tee), and the patient's blood pressure dropped significantly, indicating a cardiac tamponade.The procedure was then cancelled.Therefore, a cardiothoracic (ct) surgeon was immediately notified, and heparin was reversed.The physician attempted a pericardiocentesis but struggled to get the equipment into the pericardial space.The patient vitals were being maintained with medication while the physician continued to navigate into the pericardial space.By the time a drain was properly placed, the pericardial space had thrombosed enough to significantly slow the bleeding from the perforation and the patient's hemodynamics started to stabilize without the use of extra medication.Due to the blood in the pericardial space being mostly clotted, not much fluid/blood was able to drain.At this time, the physician and ct surgeon discussed the options and ultimately decided the patient did not require surgical intervention seeing as they were stable and the blood in the pericardial space was thrombosed.The patient was then sent to the surgical intensive care unit (sicu) while still intubated and with the drain remaining in place.The pe occurred at 10:15am, at approximately 3:30pm the physician stated that they were doing well, and they were planning to extubate later.The patient was discharged on (b)(6) 2024.The device is not expected to be returned for analysis (disposed).Prior to the procedure, there was evidence of a baseline pe on tee.The patient was not on warfarin or any antiplatelet drugs at the time of procedure.A non-boston scientific introducer was used to gain femoral access.No other issues were reported.
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.A separate problem report will be filed for the versacross dilator.

• Brand Name: VERSACROSS CONNECT LAAC ACCESS SOLUTION
• Common Device Name: CATHETER, SEPTOSTOMY
• Manufacturer (Section D): BAYLIS MEDICAL COMPANY 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: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 19610174
• Report Number: 2124215-2024-38923
• Device Sequence Number: 12783627
• Product Code: DXF
• UDI-Device Identifier: 00685447012597
• UDI-Public: 00685447012597
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Report Date (Section B): 06/25/2024

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 Lot Number: 0033555702
• 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: 06/06/2024
• Initial Report FDA Received Date: 06/25/2024
• Date Device Manufactured: 02/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Life Threatening
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Weight: 50 KG