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

Lot Number VMFF120523

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

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

Event Date 08/22/2023

Event Type  Injury  

Event Description

It was reported that a pericardial effusion occurred and procedure cancellation.A trace baseline pre-existing pericardial effusion was seen prior to the start of the left atrial appendage (laa) closure procedure via transesophageal echocardiography (tee), about 1-2cm around the ventricles.During the procedure, the physician performed transeptal crossing with the versa cross connect system and a watchman access system (was).The femoral vein access was done, then the physician requested 10.000 units of heparin to be administered.As the system was being positioned in a mid/mid position on the small fossa ovalis, the physician ordered the radiofrequency (rf) buzz.Bubbles were observed in the left atrium (la), but could not visualize the versacross rf wire going across due to the anatomy.The versacross rf wire was seen using fluoroscopy imaging and looked as if it did not cross the septum.The physician ordered the rf buzz again, now on the mid-posterior / mid.Right after the transseptal puncture was achieved, it was noticed that the baseline trace pericardial effusion had noticeably increased at the same time as the patient's pressures started to decrease (about 20 min into the procedure).The physician made the decision to abort the watchman procedure and immediately prepped for a pericardiocentesis tap.The physician immediately reversed the heparin with protamine.There was about 300 cc of blood/fluid tapped out of the pericardial space to resolve the effusion.The patient's pressures began to resolve back to normal.The patient was admitted to the hospital for overnight observation.The pericardial effusion was assumed to be in the upper pulmonary vein, as per the physician.Multiple attempts required to track up / drop down into position on septum before tsp was performed.The patient was under plavix (antiplatelet) at the time.It has been defined as a medical reason for the pericardial effusion an aortic aneurysm that made the physician aim more posterior with the transseptal.The act therapeutic during the procedure was within range 200-300.No issues with the devices were reported.In the physicians opinion, the transseptal device contribute to the patient complication.The device is not expected to be returned for analysis.

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.

Manufacturer Narrative

The device has not been received for analysis.The field b5 'describe event or problem" was updated, thus the supplemental report will be field.If there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported that a pericardial effusion occurred.A trace baseline pre-existing pericardial effusion was seen prior to the start of the left atrial appendage (laa) closure procedure via transesophageal echocardiography (tee), about 1-2cm around the ventricles.During the procedure, the physician performed transeptal crossing with the versa cross connect system and a watchman access system (was).The femoral vein access was done, then the physician requested 10.000 units of heparin to be administered.As the system was being positioned in a mid/mid position on the small fossa ovalis, the physician ordered the radiofrequency (rf) buzz.Bubbles were observed in the left atrium (la), but could not visualize the versacross rf wire going across due to the anatomy.The versacross rf wire was seen using fluoroscopy imaging and looked as if it did not cross the septum.The physician ordered the rf buzz again, now on the mid-posterior / mid.Right after the transseptal puncture was achieved, it was noticed that the baseline trace pericardial effusion had noticeably increased at the same time as the patient's pressures started to decrease (about 20 min into the procedure).The physician made the decision to abort the watchman procedure and immediately prepped for a pericardiocentesis tap.The physician immediately reversed the heparin with protamine.There was about 300 cc of blood/fluid tapped out of the pericardial space to resolve the effusion.The patient's pressures began to resolve back to normal.The patient was admitted to the hospital for overnight observation.The pericardial effusion was assumed to be in the upper pulmonary vein, as per the physician.Multiple attempts required to track up / drop down into position on septum before tsp was performed.The patient was under plavix (antiplatelet) at the time.It has been defined as a medical reason for the pericardial effusion an aortic aneurysm that made the physician aim more posterior with the transseptal.The act therapeutic during the procedure was within range 200-300.The device is not expected to be returned for analysis.No issues with the devices were reported.In the physicians opinion, the transseptal device contribute to the patient complication.On 27sep2023 was further confirmed that it was intentional for the versacross rf wire to be positioned in the left upper pulmonary vein, and no excessive pressure was applied into the patient anatomy during transseptal.

• 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: 17773684
• MDR Text Key: 323728998
• Report Number: 2124215-2023-49359
• 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,Followup
• Report Date: 10/23/2023

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
• Device Lot Number: VMFF120523
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/22/2023
• Initial Date FDA Received: 09/19/2023
• Supplement Dates Manufacturer Received: 09/27/2023
• Supplement Dates FDA Received: 10/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Race: Black Or African American