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

Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)
Date of Event	04/17/2024
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
It was reported that a pericardial effusion (pe) occurred.The procedure was cancelled.During a watchman procedure, a versacross connect access solution kit was selected for use.On the first and second transseptal puncture (tsp) attempt, bubbles could be seen in the left atrium, however the devices were unable to advance across the septum.On the third attempt, the physician was able to cross the septum along with the versacross connect, watchman sheath and an intracardiac echocardiogram (ice) catheters.As the ice catheter was in the left atrium, the patient's blood pressure began to drop and a 1-2cm pe was identified predominately around the right ventricle, though it was found circumferential.Thus, protamine was quickly given and a pericardiocentesis was performed with 475ml of blood drained.Also, medications were given to stabilize the blood pressure.The pe had resolved, the blood pressure stabilized, and the patient was transferred to the intensive care unit for overnight monitoring.The device is not expected to be returned for analysis.The patient was not under warfarin not antiplatelet drugs at the time.It was further confirmed that the patient had difficult anatomy, contributing to the versacross rf wire to do not cross in first two attempts.All three attempts were performed using the same versacross kit.There were multiple attempts required to track up / drop down into position on septum before tsp was performed.Act therapeutic during the procedure.Upon third attempt completion, then the effusion was noted quickly after.No reported allegations of malfunction for the versacross devices (rf wire or dilator), and neither the implanter expressed a concern that the versacross rf wire or dilator had contributed to the patient complication.

• 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: 19259558
• Report Number: 2124215-2024-27748
• Device Sequence Number: 6493214
• Product Code: DRE
• UDI-Device Identifier: 00685447012566
• UDI-Public: 00685447012566
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 05/07/2024

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): Initial
• Initial Date Received by Manufacturer: 04/17/2024
• Initial Report FDA Received Date: 05/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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; Life Threatening; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Female