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

Lot Number	0034508362
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Codes	Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	09/16/2024
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 pericardial effusion (pe) and a cardiac tamponade occurred.It has been reported that a versacross connect laac access solution kit was selected for use for a left atrial appendage closure (laac) procedure.The procedure was completed, when the watchman sheath and ice (philips 4d) catheter were pulled back into the right atrium (ra), a large concentric effusion measuring 11.7mm was noted around the right and left ventricules on transesophageal echocardiography (tee).A tamponade was noted, and the patient was hemodynamically unstable (sbp 40mmhg).Pericardiocentesis performed removing 420cc of bloody fluid from pericardium which was transfused back to the patient.The drain was left in pericardium and removed several hours later after a transthoracic echocardiogram (tte) was performed.No additional fluid was seen nor was any drainage seen in the bag.There were no further patient complications reported, and the patient was discharged the next day.The patient has been successfully discharged.Product is not expected to return for analysis (disposed).No pe was noted prior to the procedure.The patient was not under warfarin but taking eliquis at the time.The physician and transesophageal echocardiography (tee) imager suspected that the effusion was due to the ice catheter since the transeptal puncture was difficult due to a lipomatous septum and narrow window to puncture fossa ovalis.The physician does not believe the versacross rf wire and dilator malfunctioned during the procedure or contributed to the ae.

• 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: 20369202
• Report Number: 2124215-2024-62031
• Device Sequence Number: 17857475
• Product Code: DXF
• UDI-Device Identifier: 00685447012573
• UDI-Public: 00685447012573
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Report Date (Section B): 10/04/2024

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: 0034508362
• 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: 09/16/2024
• Initial Report FDA Received Date: 10/04/2024
• Date Device Manufactured: 03/06/2024
• 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
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Race: White