MAUDE Adverse Event Report: BAYLIS MEDICALE CIE INC VERSACROSS CONNECT LAAC ACCESS SOLUTION; CATHETER, SEPTOSTOMY

Lot Number	VMFM110623
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Difficult to Advance (2920); Positioning Problem (3009)
Health Effect - Clinical Codes	Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	08/13/2024
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 perforation occurred and the procedure was cancelled.It was reported that a versacross connect laac access solution kit was selected for use for a watchman procedure.During the procedure, the physician mentioned that patient had a double inter atrial septum.The versacross connect and double curve sheath were used to cross septum.On the first transseptal attempt, they were only able to cross 1 of the 2 septums and proceeded to begin tenting the second septum.Although, since the desired location could not be achieved, they decided to pull out and try to re-position.On the 2nd attempt, transseptal puncture was successfully, but appeared to puncture the back of the left atrial wall.The versacross wire and sheath were not seen in the left atrium after transseptal but could be seen past the septum.The physician then removed the versacross dilator and advanced the watchman sheath along with the non-boston scientific 6f pigtail catheter.The pigtail catheter was also not seen in the left atrium.The physician then decided to inject contrast, which filled the pericardial sac, allowing the physician to confirm the perforation through transesophageal echocardiography (tee) imaging.The patient was said to be hemodynamically stable the entire time, no ecg changes, and no pericardial effusion (pe) noted.Protamine was given and the patient was sent for cardiothoracic surgery (ct) surgery (ligated laa and perforation repaired).The patient has been successfully discharged.The device is not expected to be returned for analysis (disposed).The patient was not under warfarin nor antiplatelet at the time.There were no difficulties with transseptal involving the versacross dilator.Rf was applied two times using the same rf wire.The physician does not believe the versacross rf wire or dilator malfunctioned during the procedure and does not believe the dilator contributed to the ae.Act was therapeutic throughout the procedure.
Additional Manufacturer Narrative
Due to additional information received from medical safety, the fields f10 and h6 (patient codes) were updated.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 perforation occurred and the procedure was cancelled.It was reported that a versacross connect laac access solution kit was selected for use for a watchman procedure.During the procedure, the physician mentioned that patient had a double inter atrial septum.The versacross connect and double curve sheath were used to cross septum.On the first transseptal attempt, they were only able to cross 1 of the 2 septums and proceeded to begin tenting the second septum.Although, since the desired location could not be achieved, they decided to pull out and try to re-position.On the 2nd attempt, transseptal puncture was successfully, but appeared to puncture the back of the left atrial wall.The versacross wire and sheath were not seen in the left atrium after transseptal but could be seen past the septum.The physician then removed the versacross dilator and advanced the watchman sheath along with the non-boston scientific 6f pigtail catheter.The pigtail catheter was also not seen in the left atrium.The physician then decided to inject contrast, which filled the pericardial sac, allowing the physician to confirm the perforation through transesophageal echocardiography (tee) imaging.The patient was said to be hemodynamically stable the entire time, no ecg changes, and no pericardial effusion (pe) noted.Protamine was given and the patient was sent for cardiothoracic surgery (ct) surgery (ligated laa and perforation repaired).The patient has been successfully discharged.The device is not expected to be returned for analysis (disposed).The patient was not under warfarin nor antiplatelet at the time.There were no difficulties with transseptal involving the versacross dilator.Rf was applied two times using the same rf wire.The physician does not believe the versacross rf wire or dilator malfunctioned during the procedure and does not believe the dilator contributed to the ae.Act was therapeutic throughout the procedure.

• Brand Name: VERSACROSS CONNECT LAAC ACCESS SOLUTION
• Common Device Name: CATHETER, SEPTOSTOMY
• Manufacturer (Section D): BAYLIS MEDICALE CIE 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: 20134486
• Report Number: 2124215-2024-55029
• Device Sequence Number: 7447015
• Product Code: DXF
• UDI-Device Identifier: 00685447012597
• UDI-Public: 00685447012597
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 11/06/2024

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: 08/03/2025
• Device Lot Number: VMFM110623
• 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: 08/13/2024
• Supplement Date Received by Manufacturer: 11/05/2024
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 11/06/2024
• Date Device Manufactured: 06/22/2023
• 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: 66 YR
• Patient Sex: Female