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

Lot Number	0033359086
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Perforation of Vessels (2135); Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	06/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a perforation, a pericardial effusion and a cardiac tamponade occurred.The procedure was cancelled.During a watchman procedure, a versacross connect access solution kit was selected for use.It was mentioned that the versacross connect and sheath were place at the superior vena cava (svc), then it was tracked towards the septum using transesophageal echocardiogram (tee) guidance.A mid/mid location on the septum was noted by the physician and transseptal was performed, however, the aorta was perforated.The patient had a pericardial effusion (pe), which grew into a cardiac tamponade, followed by pulseless electrical activity (pea).The physician was able to tap the chest and place a drain.The patient was then immediately taken for open heart surgery and had mass transfusion.Patient was last to be extubated but still remains in the icu.Product is not expected to return for analysis (disposed).There was no pe noted prior to the procedure.No difficulties with transseptal involving the dilator were reported and the physician does not believe it contributed to the adverse event.Although, there was difficult anatomy which made it hard to image and it was reportedly difficult to visualize the versacross rf wire.Half dose of heparin was given, which was reversed as soon as the pe was noted.
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 conclusion has yet to be established as the investigation is incomplete.
Event or Problem Description
It was reported that a perforation, a pericardial effusion and a cardiac tamponade occurred.The procedure was cancelled.During a watchman procedure, a versacross connect access solution kit was selected for use.It was mentioned that the versacross connect and sheath were place at the superior vena cava (svc), then it was tracked towards the septum using transesophageal echocardiogram (tee) guidance.A mid/mid location on the septum was noted by the physician and transseptal was performed, however, the aorta was perforated.The patient had a pericardial effusion (pe), which grew into a cardiac tamponade, followed by pulseless electrical activity (pea).The physician was able to tap the chest and place a drain.The patient was then immediately taken for open heart surgery and had mass transfusion.Patient was last to be extubated but still remains in the icu.Product is not expected to return for analysis (disposed).There was no pe noted prior to the procedure.No difficulties with transseptal involving the dilator were reported and the physician does not believe it contributed to the adverse event.Although, there was difficult anatomy which made it hard to image and it was reportedly difficult to visualize the versacross rf wire.Half dose of heparin was given, which was reversed as soon as the pe was noted.It was further mentioned that the patient was discharged to rehab on (b)(6) 2024.
Additional Manufacturer Narrative
Due to additional information received, the field b5 (describe event or problem) was updated.Thus, this supplemental report is being filed.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.

• 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: 19703256
• Report Number: 2124215-2024-42167
• Device Sequence Number: 11688055
• 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
• 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): 07/11/2024

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: 0033359086
• 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: 06/17/2024
• Supplement Date Received by Manufacturer: 07/02/2024
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 07/11/2024
• 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: 67 YR
• Patient Sex: Female
• Patient Race: White