MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY INC. VERSACROSS CONNECT LAAC ACCESS SOLUTION; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Lot Number VMFH290523

Device Problem Difficult to Advance (2920)

Patient Problems Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)

Event Date 10/24/2023

Event Type  Injury  

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 Description

It was reported that a versacross connect access solution was selected for use during a watchman procedure.A pericardial effusion occurred and the procedure was cancelled.During transseptal prominent eustachian valve of the inferior vena cava - ivc was making it difficult to get to the superior vena cava - svc.The physician used the versacross rf wire to advance to the svc, but was unable to advance to it.Then, he inserted the mechanical guidewire and it was unable to get to the svc.A non-boston scientific glidewire was inserted, and it went to the svc via a non-boston mpa2 5fr diagnostic catheter.The diagnostic catheter was removed.The versacross connect and the was double curve sheath were advanced to the svc.The patient pressure started dropping and pressors was given to stabilize the blood pressure.A pericardial effusion was seen on transesophageal echocardiogram (tee) and pericardial tap was then performed.A total of 500ml of fluid was removed from the lateral wall and right atrium.The procedure was cancelled.A drained was left and the patient remained in intensive care unit for two days, fully recovered and was discharged(b)(6) 2023.The device is not expected to be returned for analysis (disposed).In the physician's opinion, the versacross connect contributed to the patient complication, since during attempt to get tsp the eustachian valve was in the way and the physician had difficulty getting up to the svc.The patient was admitted to hospital beyond the standard of care.No pe was noted prior to tsp.The transseptal puncture was not obtained.The patient had no oac on board.The patient was not on antiplatelet drugs at this time.No known medical reason for the pericardial effusion.A versacross rf wire, a mechanical guidewire and a non-boston scientific glidewire were used and pulled down several times.There were difficulties with imagining the anatomy.There was some force used to try to advance the wire and sheath to the svc.The radio frequency was not attempted at all the system was removed and pericardial tap began.No other issues with transseptal devices were noted.

• Brand Name: VERSACROSS CONNECT LAAC ACCESS SOLUTION
• Type of Device: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• 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: 18187212
• MDR Text Key: 328741337
• Report Number: 2124215-2023-63084
• Device Sequence Number: 1
• Product Code: DRE
• UDI-Device Identifier: 00685447012597
• UDI-Public: 00685447012597
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K220414
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: VMFH290523
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Race: White