MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY INC. VERSACROSS CONNECT LAAC ACCESS SOLUTION; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Lot Number	0033655204
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	08/16/2024
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
A perforation, a pericardial effusion (pe) and cardiac tamponade occurred.It was reported that a versacross connect laac access solution kit was selected for use for a watchman procedure.The physician attempted re-position for transseptal puncture several times, and it was needed to remove the versacross dilator and was sheath twice to add curve, before they were able to position onto fossa in an inferior and mid position.The rf energy was applied three (3) times, but it was unsuccessful due to poor septal contact.Next, they switched to an inferior/low position due to the presence of multiple pacemaker lead in the right atrium and were able to gain transseptal access, crossing successfully (utilizing a transesophageal echocardiogram (tee) view to confirm contact with the fossa, the correct tsp position was obtained).The versacross wire and watchman sheath were then advanced to the ostium of the left atrial appendage (laa).At this point, the patient's blood pressure began declining.A (tee) was then performed which revealed a pe beginning, and that he patient's right atrial lead had moved from its original position.Pericardiocentesis was then performed, stabilizing the patient briefly.The physician then made the decision to continue the watchman implant.A 27mm watchman flx was implanted successfully with 3 partial recaptures needed.Following this, the patient was noted to have a slight decline in blood pressure once again.Another tee scan was performed and found that the pe had grown in size.More fluid was extracted, approximately 1800ml in total, and a surgeon was called in to repair the perforation.While performing the surgery, it was confirmed there was perforation in the right atrium.Patient has been transferred to the intensive care unit (icu) and has been discharged home.The device is not expected to be returned for analysis.Prior to the procedure, no pe was noted on echo.The pe began in the left atrium and then expanded circumferentially around the heart.The patient was on plavix and dapt at the time of procedure.The physician believes that they may have perforated it with the tip of the dilator while positioning for transseptal, since they had to add additional curve to the dilator due to the presence of leads and may have perforated the right atrium when clocking and counter clocking to find the transseptal position.The rf wire was not protruding out of the dilator when the issue was noted.The physician does not believe the versacross dilator or rf wire malfunctioned during the procedure, and that the versacross rf wire did not contribute to the adverse event.

• Brand Name: VERSACROSS CONNECT LAAC ACCESS SOLUTION
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• 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: angela hinkley ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 20128676
• Report Number: 2124215-2024-54970
• Device Sequence Number: 16919471
• Product Code: DRE
• UDI-Device Identifier: 00685447012597
• UDI-Public: 00685447012597
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K220414
• 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): 09/03/2024

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: 0033655204
• 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: 08/16/2024
• Initial Report FDA Received Date: 09/03/2024
• Date Device Manufactured: 02/23/2024
• 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: 81 YR
• Patient Sex: Male
• Patient Race: White