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

Lot Number	VMFB210923
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	04/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a pericardial effusion and cardiac tamponade occurred.The procedure was cancelled.During a watchman left atrial appendage closure (laac), a versacross connect kit was selected for use.The transseptal puncture (tsp) was performed successfully and the sheath was advanced across the septum.The versacross dilator was removed and pigtail was inserted into the left atrial appendage (laa).At that time the anesthesiologist noted a drop in patients' blood pressure and an effusion was noted via transesophageal echocardiogram (tee).A central line was placed and pericardiocentesis was performed.The patient was stabilized, was transferred for further observation and remains in the hospital, expected to fully recover.The device is not expected to be returned for analysis.The physician believes the effusion occurred either during crossing of septum or post tsp, after the pigtail inserted into laa.No pe was noted prior to the procedure.The patient was not under warfarin at the time of event, but it was under pradaxa.
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
It was reported that a pericardial effusion and cardiac tamponade occurred.The procedure was cancelled.During a watchman left atrial appendage closure (laac), a versacross connect kit was selected for use.The transseptal puncture (tsp) was performed successfully and the sheath was advanced across the septum.The versacross dilator was removed and pigtail was inserted into the left atrial appendage (laa).At that time the anesthesiologist noted a drop in patients' blood pressure and an effusion was noted via transesophageal echocardiogram (tee).A central line was placed and pericardiocentesis was performed.The patient was stabilized, was transferred for further observation and remains in the hospital, expected to fully recover.The device is not expected to be returned for analysis.The physician believes the effusion occurred either during crossing of septum or post tsp, after the pigtail inserted into laa.No pe was noted prior to the procedure.The patient was not under warfarin at the time of event, but it was under pradaxa.It was later confirmed that the physician does not feel the equipment caused the event.When radio frequency was applied, the tee physician could not follow across the septum.There were no multiple attempts required at tsp.The lot number for the kit used was vmfb210923.
Additional Manufacturer Narrative
Due to the additional information received on 30apr2024, the fields b5 (describe event or problem) and d4 (lot number, expiration date) were updated, thus this supplemental mdr is being filed.The device did not return 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: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 19216370
• Report Number: 2124215-2024-26110
• Device Sequence Number: 12788544
• Product Code: DXF
• UDI-Device Identifier: 00685447012566
• UDI-Public: 00685447012566
• 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): 05/17/2024

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: 07/17/2026
• Device Lot Number: VMFB210923
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/10/2024
• Supplement Date Received by Manufacturer: 04/30/2024
• Initial Report FDA Received Date: 04/30/2024
• Supplement Report FDA Received Date: 05/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2023
• 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; Hospitalization; Life Threatening
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Race: White