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

Lot Number	VMFA110823
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Material Deformation (2976); Positioning Problem (3009)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	07/11/2024
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.A separate problem report will be field for the versacross dilator.
Event or Problem Description
A pericardial effusion (pe) occurred, the procedure was cancelled.During the procedure, a versacross connect access solution kit was selected for use for a left atrial appendage closure (laac) procedure.The patient was intubated by general anesthesia.Transesophageal echocardiography (tee) was performed prior to the procedure and a small pleural effusion was noted at right ventricle.The groin access was obtained and the versacross rf wire was advanced into the superior vena cava (svc) towards the septum.Following three unsuccessful attempts to obtain an appropriate location and visualization on the septum, an effusion was noted on tee around the right atrium (rt).At this point, the physician stopped the procedure, reversed heparin was given, and monitored the effusion, which was deemed stable shortly after, as well as the patient.The patient was then admitted for overnight observation for a follow-up echocardiogram.The follow-up performed next day showed minimal effusion and the patient was discharged.Product is not expected to return for analysis.(disposed).The small pleural effusion around the right ventricle noted prior to the procedure remained unchanged in size when the pericardial effusion occurred.The patient was not under warfarin, but it was under eliquis at the time of procedure.It was not possible to determine at what point the pe occurred, and transseptal puncture was never performed (rf was not applied).It was reported that the versacross rf wire and dilator had an issue with positioning, to get location on septum, repositioned into svc multiple times to drop again.Also, it was reported an issue with visualization of the rf wire on tee, and the rf wire did appear to have a slight kink toward distal end when removed (physician commented that might have occurred when he tried advancing sheath and rf wire together).In the physician's opinion, they are unsure what caused the pe and whether or not the versacross devices contributed to the event.
Event or Problem Description
A pericardial effusion (pe) occurred; the procedure was cancelled.During the procedure, a versacross connect access solution kit was selected for use for a left atrial appendage closure (laac) procedure.The patient was intubated by general anesthesia.Transesophageal echocardiography (tee) was performed prior to the procedure and a small pleural effusion was noted at right ventricle.The groin access was obtained and the versacross rf wire was advanced into the superior vena cava (svc) towards the septum.Following (b)(4) unsuccessful attempts to obtain an appropriate location and visualization on the septum, an effusion was noted on tee around the right atrium (rt).At this point, the physician stopped the procedure, reversed heparin was given, and monitored the effusion, which was deemed stable shortly after, as well as the patient.The patient was then admitted for overnight observation for a follow-up echocardiogram.The follow-up performed next day showed minimal effusion and the patient was discharged.Product is not expected to return for analysis (disposed).The small pleural effusion around the right ventricle noted prior to the procedure remained unchanged in size when the pericardial effusion occurred.The patient was not under warfarin, but it was under eliquis at the time of procedure.It was not possible to determine at what point the pe occurred, and transseptal puncture was never performed (rf was not applied).It was reported that the versacross rf wire and dilator had an issue with positioning, to get location on septum, repositioned into svc multiple times to drop again.Also, it was reported an issue with visualization of the rf wire on tee, and the rf wire did appear to have a slight kink toward distal end when removed (physician commented that might have occurred when he tried advancing sheath and rf wire together).In the physician's opinion, they are unsure what caused the pe and whether or not the versacross devices contributed to the event.It was further confirmed that the pre-existing effusion noted was a pericardial effusion and not a pleural effusion as originally mentioned.
Additional Manufacturer Narrative
Due to additional information received, the field b5 (describe event or problem) was updated.Thus, this supplemental mdr 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): BAYLIS MEDICAL COMPANY INC.; 5825 explorer drive; mississauga, on L4W 5 P6; CA L4W 5P6
• Manufacturer Contact: angela hinkley ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 19874761
• Report Number: 2124215-2024-47389
• Device Sequence Number: 7778051
• Product Code: DXF
• UDI-Device Identifier: 00685447012566
• UDI-Public: 00685447012566
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 09/04/2024

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 Expiration Date: 05/02/2026
• Device Lot Number: VMFA110823
• 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: 07/11/2024
• Supplement Date Received by Manufacturer: 08/19/2024
• Initial Report FDA Received Date: 07/31/2024
• Supplement Report FDA Received Date: 09/04/2024
• Date Device Manufactured: 08/16/2023
• 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; Required Intervention; Hospitalization
• Patient Age: 85 YR
• Patient Sex: Female