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

Lot Number	0033573015
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	08/20/2024
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 pericardial effusion (pe) occurred, and the procedure was cancelled.It was reported that a versacross connect laac access solution kit was selected for use for a watchman procedure.During the procedure, the versacross connect and watchman sheat were positioned into the superior vena cava (svc) and were drug down to the septum.It was tough to image the septum.They were able to cross successfully using the versacross rf wire (low and post position), and the versacross rf wire was seen in the left atrium (la).Next, they advanced the watchman double curve sheath through the septum, requiring extra force due to resistance being felt.At this point, a pe was noted in the post wall, protamine was given, and the procedure was cancelled.They watched the effusion for roughly 30 minutes, and no change was observed.The patient was then taken to the intensive care unit (icu) for recovery, and it was discharge from the hospital.Product is not expected to return for analysis as it was disposed of at the facility.The physician believes they may have nicked the posterior wall with the versacross rf wire, right after crossing.A trace of pe was noted prior to the procedure.No other intervention was required.Heparin had also been given to the patient, who was not under antiplatelet at the time.

• 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: angela hinkley ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 20171823
• Report Number: 2124215-2024-56192
• Device Sequence Number: 12513251
• Product Code: DXF
• UDI-Device Identifier: 00685447012597
• UDI-Public: 00685447012597
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K150709
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 09/09/2024

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?: Yes
• Operator of Device: Health Professional
• Device Lot Number: 0033573015
• 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: 08/20/2024
• Initial Report FDA Received Date: 09/09/2024
• 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: Life Threatening; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Race: White