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

Device Problem Difficult to Advance (2920)

Patient Problems Cardiac Tamponade (2226); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 02/03/2023

Event Type  Injury  

Manufacturer Narrative

Additional pro code dxf the device won't be returned for analysis.Upon evaluation of the failure analysis of the event reported, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported that the patient experienced a pericardial effusion with cardiac tamponade.A left atrial appendage (laa) closure procedure was being performed.A watchman access system (was), a 35mm watchman flx laa closure device & delivery system (wds) and a versacross access solution were selected to be used.It was noted that there was a trace pericardial effusion prior to the start of the procedure.The physician gained right femoral vein access and inserted the watchman fxd double curve sheath with the acucross dilator inside.Using transesophageal echocardiogram (tee), a transseptal puncture was attempted several times.However, it was noted that the sheath/dilator combo was never perpendicular to the fossa.Additionally, the sheath/dilator would ride up the fossa and was unstable every time physician attempted to deploy the needle.The physician had to push the 0.035' wire out into the right atrium (ra) again and pull down several times.Transeptal (tsp) was finally achieved (although not in an ideal location - superior and mid tsp).The fxd curve was advanced to the left atrium (la) and a pigtail inserted.An appendagram was obtained.Although trajectory was noted to be off, it was decided to attempt a flx 31mm device.The 31mm device could never be coaxial with the landing zone so another tsp was discussed.Everything was pulled to the right side and a pericardial effusion check was performed and there did not appear to be an increase in effusion from baseline.A more inferior and mid-to-posterior tsp was accomplished with a versacross system.The same fxd double curve sheath was inserted to the la.Another 31mm device was attempted but a leak was still visualized.A 35 mm device was then attempted.This device showed better tissue contact.After a strong tug test, measurements were made on tee.A contrast shot was performed and there did not appear to be any color on tee.Pass criteria was met and the device was released.A final pericardial effusion check was performed and there still did not appear to be any change to the baseline.In the post-anesthesia care unit (pacu), the patient went into tamponade and a tte showed significant pericardial effusion.The patient was brought back emergently to the cardiac catheterization lab where a physician performed a pericardial tap and roughly 500cc of blood was removed from the pericardium.The patient remains in the hospital, but it expected to make a full recovery.The physician felt like the blood was 'dark' and he feels that it was caused during the difficult transseptal at the beginning of the case.It was further reported that the patient was discharged from the hospital and is currently alive and well.

• Brand Name: VERSACROSS ACCESS SOLUTION
• Type of Device: INTRODUCER, CATHETER
• 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 H4T 1 A1; CA H4T 1A1
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 17543616
• MDR Text Key: 321133436
• Report Number: 2124215-2023-43248
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183655
• 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: 08/14/2023

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: 02/03/2023
• Initial Date FDA Received: 08/14/2023
• 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): Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Race: White