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

Model Number	VXAK0003
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	12/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a pericardial effusion (pe) occurred.During a watchman procedure indicated for a case of gastrointestinal bleeding (gib), a versacross connect for laac kit was selected for use.An intracardiac echocardiography (ice) was used, transseptal puncture was completed.A posterior effusion was noted immediately after transseptal puncture.The watchman flx device was successful deployed.Afterwards the effusion had grown to around 1.8cm and pericardiocentesis was performed.The physician felt he had no explanation for the effusion.It was theorized that in an effort to avoid pacemaker wires, the physician may have nicked something with the rf wire or with ice catheter, or the transeptal was more inferior.The patient was doing well in the hospital and expected to be discharged couple of days later.The device is not expected to be returned for analysis (disposed).No pe was noted prior to the procedure.The patient was not under warfarin nor antiplatelet drugs at the time.In the physician's opinion, the device/procedure did not contribute to the patient complication.
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.
Additional Manufacturer Narrative
Due to additional information received, this supplemental report is being filed for the update fields: describe event or problem (b5) in section b - adverse event/product prob; model number, lot number, catalog number, expiration date, unique identifier (udi) # (d4), in section d - suspect medical device; mfr site facility name, mfr site address 1, mfr site city, mfr site state, mfr site zip/post code and mfr site country (g1), in section g - all manufacturers.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 a pericardial effusion (pe) occurred.During a watchman procedure indicated for a case of gastrointestinal bleeding (gib), a versacross connect for laac kit was selected for use.An intracardiac echocardiography (ice) was used, transseptal puncture was completed.A posterior effusion was noted immediately after transseptal puncture.The watchman flx device was successful deployed.Afterwards the effusion had grown to around 1.8cm and pericardiocentesis was performed.The physician felt he had no explanation for the effusion.It was theorized that in an effort to avoid pacemaker wires, the physician may have nicked something with the rf wire or with ice catheter, or the transeptal was more inferior.The patient was doing well in the hospital and expected to be discharged couple of days later.The device is not expected to be returned for analysis (disposed).No pe was noted prior to the procedure.The patient was not under warfarin nor antiplatelet drugs at the time.In the physician's opinion, the device/procedure did not contribute to the patient complication.It was further confirmed that the versacross device did not malfunction or seemed to contribute to patient complication.Activated clotting time (act) was 258.The patient remained hemodynamically stable during procedure.The patient has been discharged.

• 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): BOSTON SCIENTIFIC CORPORATION; zona franca la lima; cartgo, 03 30106 ; CS 30106
• Manufacturer Contact: angela hinkley ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 20988588
• Report Number: 2124215-2024-81001
• Device Sequence Number: 8600355
• Product Code: DXF
• UDI-Device Identifier: 00685447018346
• UDI-Public: 00685447018346
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 02/11/2025

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 Model Number: VXAK0003
• Device Catalogue Number: VXAK0003
• Device Lot Number: 0034545978
• 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: 12/10/2024
• Supplement Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 12/20/2024
• Supplement Report FDA Received Date: 02/11/2025
• Date Device Manufactured: 04/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Race: White