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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arrhythmia (1721); Cardiac Arrest (1762); Intracranial Hemorrhage (1891); Low Blood Pressure/ Hypotension (1914)

Event Date 11/28/2022

Event Type  Injury  

Event Description

It was reported that an air embolism occurred.A left atrial appendage (laa) closure procedure was being performed.A watchman access system (was), a watchman flx laa closure device & delivery system (wds), and a versacross connect laac access solution and nrg rf transseptal needle were selected to be used.The physician performed the transseptal puncture and then inserted the was.With the was positioned in the laa of the patient the wds was inserted.The physician deployed a 24mm closure device, but it did not meet release criteria.The device was fully recaptured and removed from the patient.A new transseptal puncture was performed at a more inferior position.After more than 20 minutes of trying the physician finally succeeded in achieving a new transseptal position.The physician positioned the was in the laa of the patient and continued the procedure.At this point in the procedure the patient's blood pressure began to drop, a perforation was ruled out, but the patient still decompensated.The patient was noted to have an av block and they went into cardiac arrest.Cardiopulmonary resuscitation was performed, and the patient was given epinephrine.After three minutes the patient's pulse returned.After an additional ten minutes while the patient remained stable the physician decided to continue the procedure.Before the procedure could be continued the patient decompensated a second time.The patient's blood pressured dropped again and the patient was given medication before becoming stable again.The physician ended the procedure with no closure device implanted and the patient will be kept overnight for observation.That night the patient experienced a cerebral vascular accident.A computed tomography scan was performed, and a subarachnoid hemorrhage was found.The patient is currently still hospitalized in the intensive care unit and is not responsive.

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.

• 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 ; CA
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 17624647
• MDR Text Key: 321965197
• Report Number: 2124215-2023-45855
• Device Sequence Number: 1
• Product Code: DRE
• 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: 08/25/2023

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2022
• Initial Date FDA Received: 08/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention; Disability
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 69 KG
• Patient Race: Black Or African American