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

Lot Number	VXF121223K
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	05/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a perforation and a pericardial effusion occurred.During a watchman left atrial appendage closure (laac) procedure, a versacross access solution kit was selected for use.The access was granted and the transseptal puncture (tsp) was performed without any issues.After tsp, when the versacross sheath was being placed into the left upper pulmonary vein, there was difficulty to locate the versacross rf wire, since it was very posterior.The versacross sheath was exchanged for the watchman sheath, and it was still not possible to visualize the rf wire.The watchman sheath appeared be more posterior in the left atrium.Thus, a non-boston scientific pigtail was placed in the appendage and a contrast injection was completed.Therefore, a small circumferential pericardial effusion was noted.The patient remained stable, so the physician completed the implant of the closure device.A pericardiocentesis was completed to treat the effusion removing 450ml of bright red fluid.The patient was reported to be doing well but remained in the hospital.The device is not expected to be returned for analysis.No pe was noted prior to the procedure.The patient was not under warfarin nor antiplatelet at the time.The physician believes that the left atrium was perforated when the versacross sheath went more posterior during tsp, causing the pe.It is possible that it was an operator error.No other issues were reported.
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 filed for the versacross rf wire.
Additional Manufacturer Narrative
The device was not returned for analysis.However, based on the media provided showing imaging of a pericardial effusion, the reported allegation of pericardial effusion was confirmed.Thus, a supplemental mdr is being filed.If there is any further relevant information obtained, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that a perforation and a pericardial effusion occurred.During a watchman left atrial appendage closure (laac) procedure, a versacross access solution kit was selected for use.The access was granted and the transseptal puncture (tsp) was performed without any issues.After tsp, when the versacross sheath was being placed into the left upper pulmonary vein, there was difficulty to locate the versacross rf wire, since it was very posterior.The versacross sheath was exchanged for the watchman sheath, and it was still not possible to visualize the rf wire.The watchman sheath appeared be more posterior in the left atrium.Thus, a non-boston scientific pigtail was placed in the appendage and a contrast injection was completed.Therefore, a small circumferential pericardial effusion was noted.The patient remained stable, so the physician completed the implant of the closure device.A pericardiocentesis was completed to treat the effusion removing 450ml of bright red fluid.The patient was reported to be doing well but remained in the hospital.The device is not expected to be returned for analysis.No pe was noted prior to the procedure.The patient was not under warfarin nor antiplatelet at the time.The physician believes that the left atrium was perforated when the versacross sheath went more posterior during tsp, causing the pe.It is possible that it was an operator error.No other issues were reported.

• Brand Name: VERSACROSS ACCESS SOLUTION
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): BAYLIS MEDICAL COMPANY INC.; 5959 trans-canada highway; montreal H4T 1 A1; CA H4T 1A1
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA SRL; la lima business park; la lima, 03 ; CS
• Manufacturer Contact: angela hinkley ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 19569884
• Report Number: 2124215-2024-37466
• Device Sequence Number: 6974478
• Product Code: DYB
• UDI-Device Identifier: 00685447011828
• UDI-Public: 00685447011828
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K183655
• 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): 09/05/2024

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 Expiration Date: 03/03/2026
• Device Lot Number: VXF121223K
• 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: 05/30/2024
• Supplement Date Received by Manufacturer: 08/28/2024
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 09/05/2024
• Date Device Manufactured: 12/12/2023
• 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: 77 YR
• Patient Sex: Male