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

Lot Number VMFD310723

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

Patient Problems Cardiac Arrest (1762); High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Cardiac Perforation (2513); Electric Shock (2554); Pericardial Effusion (3271); Respiratory Arrest (4461)

Event Date 10/03/2023

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 left atrium appendage closure.A perforation, a pericardial effusion and a cardiac tamponade occurred.The procedure was aborted.During procedure, the right femoral was accessed (non-boston scientific introducer), the transseptal devices were up and when onto the fossa (inferior and mid position), which was clearly tenting per the transesophageal echocardiogram (tee) images.During the first attempt to deliver radio frequency (rf), it was noticed that the bmc rf generator was not plugged in.Thus, all was plugged in and, the same position again on the fossa was confirmed, another attempt to go transseptal was done (rf delivered), however, the septum was not crossed.Then, the location was once again confirmed by tee, (rf delivered), and yet, the septum was not crossed over.Therefore, the physician asked once again to deliver radio frequency after confirming placement again through the septum, rf applied and this time it worked, and the crossing of the septum to the left atrium (la) was achieved.Once across, in the la, the versacross dilator was removed to be replaced by a non-boston scientific pigtail catheter, and right before inserting the non-boston scientific pigtail catheter, the patient had moved and made the physician note on flouro the sheath going near the heart outline.Then, once the pigtail catheter was going up, the tee imager scanned over to appendage where it was noticed more fluid in the transverse sinus cavity than before.Thus, upon the effusion sweep, it has been noticed there was around the same effusion as the baseline effusion recorded before, behind left atrium.Once checking for the patients pressure from anesthesia, it has been mentioned that it was not being possible to get a proper pressure reading since the start of the case.While the staff was trying to hook up a blood pressure cuff to the patients leg, the pericardial effusion size get larger on tee.Thus, a pericardiocentesis tap to remove the fluid from the sac was started, when the patient's stats started to lower and experience cardiac tamponade, patient get hypertension thus, the physician called a code blue and started chest compressions.The team then proceeded with a defib shock at 200j and then another two times with 360j.Once the patient was back in normal rhythm, the physician finished tapping off excess fluid with the cardiac vascular surgeon, who suggested surgical intervention was not needed to happen at that time.A total of 100cc of fluid was tapped in total at this time.The patient was transferred upstairs to cardiovascular intensive care unit (cvicu) to stay the night.About 30 minutes later, the patient coded again.They said every time epi wore off, the patient's stats would tank.About three (3) rounds of chest compressions in the cvicu were done, and then it was decided to bring the patient to the operation room (or).In the or, a perforation in the right ventricle was discovered and a cardiac surgery was done, and the perforation was repaired and patient stabilized in the cvicu.A pericardial effusion was noted prior to the procedure (measuring about 1 cm), but the cause is unknown.The pe get larger before tapping it off (measuring about 3 cm).The patient was not under warfarin, and under aspirin only.Initially, the physician believes the rib punctured the right ventricle during chest compressions.After the fact, the physician mentioned that when advancing the versacross rf wire up to the superior vena cava (svc), the wire took a turn down to the right ventricle (rv), rather than superior vena cava (svc).With the bend/kink it made the versacross rf wire bend noticeably, right after taking it out from the sheath.After md got it out of the tricuspid valve, it tracked up to the svc and dropped down as normal.Thus, the physician was unsure if that caused any of the events to happen.Later on, the patient was noticed stable, staying the night for observation, and expected to fully recover.It was still hospitalized by (b)(6) 2023 (current status is unknown).A non-boston scientific introducer was used for femoral access.The patient was admitted to hospital beyond standard of care.

Manufacturer Narrative

This supplemental mdr is being field due to correction to the initial mdr report sent: e1 (initial reporter title, initial reporter address 1, initial reporter zip/post code), f10 and h6 (patient codes (7)).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 left atrium appendage closure.A perforation, a pericardial effusion and a cardiac tamponade occurred.The procedure was aborted.During procedure, the right femoral was accessed (non-boston scientific introducer), the transseptal devices were up and when onto the fossa (inferior and mid position), which was clearly tenting per the transesophageal echocardiogram (tee) images.During the first attempt to deliver radio frequency (rf), it was noticed that the bmc rf generator was not plugged in.Thus, all was plugged in and, the same position again on the fossa was confirmed, another attempt to go transseptal was done (rf delivered), however, the septum was not crossed.Then, the location was once again confirmed by tee, (rf delivered), and yet, the septum was not crossed over.Therefore, the physician asked once again to deliver radio frequency after confirming placement again through the septum, rf applied and this time it worked, and the crossing of the septum to the left atrium (la) was achieved.Once across, in the la, the versacross dilator was removed to be replaced by a non-boston scientific pigtail catheter, and right before inserting the non-boston scientific pigtail catheter, the patient had moved and made the physician note on flouro the sheath going near the heart outline.Then, once the pigtail catheter was going up, the tee imager scanned over to appendage where it was noticed more fluid in the transverse sinus cavity than before.Thus, upon the effusion sweep, it has been noticed there was around the same effusion as the baseline effusion recorded before, behind left atrium.Once checking for the patients pressure from anesthesia, it has been mentioned that it was not being possible to get a proper pressure reading since the start of the case.While the staff was trying to hook up a blood pressure cuff to the patients leg, the pericardial effusion size get larger on tee.Thus, a pericardiocentesis tap to remove the fluid from the sac was started, when the patient's stats started to lower and experience cardiac tamponade, patient get hypertension thus, the physician called a code blue and started chest compressions.The team then proceeded with a defib shock at 200j and then another two times with 360j.Once the patient was back in normal rhythm, the physician finished tapping off excess fluid with the cardiac vascular surgeon, who suggested surgical intervention was not needed to happen at that time.A total of 100cc of fluid was tapped in total at this time.The patient was transferred upstairs to cardiovascular intensive care unit (cvicu) to stay the night.About 30 minutes later, the patient coded again.They said every time epi wore off, the patient's stats would tank.About three (3) rounds of chest compressions in the cvicu were done, and then it was decided to bring the patient to the operation room (or).In the or, a perforation in the right ventricle was discovered and a cardiac surgery was done, and the perforation was repaired and patient stabilized in the cvicu.A pericardial effusion was noted prior to the procedure (measuring about 1 cm), but the cause is unknown.The pe get larger before tapping it off (measuring about 3 cm).The patient was not under warfarin, and under aspirin only.Initially, the physician believes the rib punctured the right ventricle during chest compressions.After the fact, the physician mentioned that when advancing the versacross rf wire up to the superior vena cava (svc), the wire took a turn down to the right ventricle (rv), rather than superior vena cava (svc).With the bend/kink it made the versacross rf wire bend noticeably, right after taking it out from the sheath.After md got it out of the tricuspid valve, it tracked up to the svc and dropped down as normal.Thus, the physician was unsure if that caused any of the events to happen.Later on, the patient was noticed stable, staying the night for observation, and expected to fully recover.It was still hospitalized by (b)(6) 2023 (current status is unknown).A non-boston scientific introducer was used for femoral access.The patient was admitted to hospital beyond standard of care.

• 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: 18041358
• MDR Text Key: 326989558
• Report Number: 2124215-2023-59923
• 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: 04/30/2024

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
• Device Operator: Health Professional
• Device Lot Number: VMFD310723
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/03/2023
• Initial Date FDA Received: 10/31/2023
• Supplement Dates Manufacturer Received: 10/03/2023
• Supplement Dates FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Other
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Race: White