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

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pulmonary Edema (2020)
Date of Event	05/16/2024
Type of Reportable Event	Death
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 rf wire.
Event or Problem Description
It has been reported that the patient went into flash pulmonary edema and passed away, procedure cancelled.A versacross connect access solution kit was selected for use for during a watchman (left atrial appendage closure) case.The patient was intubated, and the procedure started.While attempting to go transseptal on a difficult anatomy, the anesthesia physician started suctioning out foamy blood from the intubation tube.After some time had passed, the anesthesia physician comment that the patient was unstable, and the procedure was aborted.The patient went into flash pulmonary edema before crossing the interatrial septum.The patient was then transferred to the intensive care unit (icu), however passed away around 10:30pm that night.The physician did not suspect that the devices themselves caused or contributed to the patient death, and it was not based on a procedure complication.An official cause of death was not provided.No surgical intervention was reported.Product is not expected to return for analysis (disposed).It was further reported that the issue was noted while they were attempting to go transseptal.The watchman sheath and the versacross connect system were inside the patient at the time and the anesthesiologist took control at the time and details not disclosed.

• 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): BAYLIS MEDICAL COMPANY INC.; 5825 explorer drive; mississauga, on L4W 5 P6; CA L4W 5P6
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 19601123
• Report Number: 2124215-2024-38693
• Device Sequence Number: 15042746
• Product Code: DRE
• UDI-Device Identifier: 00685447012566
• UDI-Public: 00685447012566
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 06/24/2024

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
• 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: 06/04/2024
• Initial Report FDA Received Date: 06/24/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Life Threatening; Hospitalization
• Patient Age: 78 YR
• Patient Sex: Female