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 Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 10/17/2023

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 and cardiac tamponade were noted and the procedure was cancelled.The procedure was set up for the transeptal puncture and it was difficulty identifying where devices were on intracardiac echocardiography (ice), suspected to be due to a patient anatomy.A good tent was noted and suspected to be in a safe location.A suggestion to confirm location was done by using transesophageal echocardiogram (tee), and the physician did not seem concerned.Once proceeded to start to apply radio frequency (rf), the bmc rf generator gave the alert a005 twice.Thus, the devices were reconnected, the system was turned off and back on.Hence, the versacross rf wire was exposed 1-3 mm outside of the versacross dilator.Then, it was buzzed across, however the versacross rf wire did not seem to go into the left atrium (la) initially.There were multiple attempts required to track up / drop down into position on septum before tsp was performed.The physician retracted the versacross rf wire and was able to then advance the wire into the la.Then, it was noticed a pressure dropping rapidly and noticed a pericardial effusion had developed.A cardiac tamponade was also noted.A pericardiocentesis was performed, and heparin was reversed.The procedure was cancelled.The patient stayed overnight and was admitted to hospital beyond standard of care.The patient was discharged on (b)(6) 2023.In the physician's opinion, the device or procedure did not contribute to the patient complication(s).No pericardial effusion was noted on echo before the procedure.The pericardial effusion was posterior, and it did occur during transseptal puncture.The patient was not under warfarin and antiplatelet drugs.No medical reason was defined for the pe.The activated clotting time (act) therapeutic during the procedure was 247.No other issues were reported.The device is not expected to be returned for analysis (discarded).

Event Description

It was reported that a versacross connect access solution was selected for use during a watchman procedure.A pericardial effusion and cardiac tamponade were noted and the procedure was cancelled.The procedure was set up for the transeptal puncture and it was difficulty identifying where devices were on intracardiac echocardiography (ice), suspected to be due to a patient anatomy.A good tent was noted and suspected to be in a safe location.A suggestion to confirm location was done by using transesophageal echocardiogram (tee), and the physician did not seem concerned.Once proceeded to start to apply radio frequency (rf), the bmc rf generator gave the alert a005 twice.Thus, the devices were reconnected, the system was turned off and back on.Hence, the versacross rf wire was exposed 1-3 mm outside of the versacross dilator.Then, it was buzzed across, however the versacross rf wire did not seem to go into the left atrium (la) initially.There were multiple attempts required to track up / drop down into position on septum before tsp was performed.The physician retracted the versacross rf wire and was able to then advance the wire into the la.Then, it was noticed a pressure dropping rapidly and noticed a pericardial effusion had developed.A cardiac tamponade was also noted.A pericardiocentesis was performed, and heparin was reversed.The procedure was cancelled.The patient stayed overnight and was admitted to hospital beyond standard of care.The patient was discharged on (b)(6) 2023.In the physician's opinion, the device or procedure did not contribute to the patient complication(s).No pericardial effusion was noted on echo before the procedure.The pericardial effusion was posterior, and it did occur during transseptal puncture.The patient was not under warfarin and antiplatelet drugs.No medical reason was defined for the pe.The activated clotting time (act) therapeutic during the procedure was 247.No other issues were reported.The device is not expected to be returned for analysis (discarded).It was further confirmed that the product related to this case is (b)(6).

Manufacturer Narrative

Due to correction (13nov2023), the fields b5 (describe event or problem) and d4 (unique identifier (udi) #) were updated, thus this supplemental report is being filed.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

Udi related data quality updates only this report is being filed as a correction in response to an fda request for the complete the unique identifier (udi) #.Additionally, the field e1 (initial reporter fax) was updated.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 and cardiac tamponade were noted and the procedure was cancelled.The procedure was set up for the transeptal puncture and it was difficulty identifying where devices were on intracardiac echocardiography (ice), suspected to be due to a patient anatomy.A good tent was noted and suspected to be in a safe location.A suggestion to confirm location was done by using transesophageal echocardiogram (tee), and the physician did not seem concerned.Once proceeded to start to apply radio frequency (rf), the bmc rf generator gave the alert a005 twice.Thus, the devices were reconnected, the system was turned off and back on.Hence, the versacross rf wire was exposed 1-3 mm outside of the versacross dilator.Then, it was buzzed across, however the versacross rf wire did not seem to go into the left atrium (la) initially.There were multiple attempts required to track up / drop down into position on septum before tsp was performed.The physician retracted the versacross rf wire and was able to then advance the wire into the la.Then, it was noticed a pressure dropping rapidly and noticed a pericardial effusion had developed.A cardiac tamponade was also noted.A pericardiocentesis was performed, and heparin was reversed.The procedure was cancelled.The patient stayed overnight and was admitted to hospital beyond standard of care.The patient was discharged on (b)(6) 2023.In the physician's opinion, the device or procedure did not contribute to the patient complication(s).No pericardial effusion was noted on echo before the procedure.The pericardial effusion was posterior, and it did occur during transseptal puncture.The patient was not under warfarin and antiplatelet drugs.No medical reason was defined for the pe.The activated clotting time (act) therapeutic during the procedure was 247.No other issues were reported.The device is not expected to be returned for analysis (discarded).It was further confirmed that the product related to this case is (b)(4).

• 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: 18085977
• MDR Text Key: 327550974
• Report Number: 2124215-2023-62093
• 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,Followup,Followup
• Report Date: 07/29/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/17/2023
• Initial Date FDA Received: 11/07/2023
• Supplement Dates Manufacturer Received: 11/13/2023; 07/09/2024
• Supplement Dates FDA Received: 11/30/2023; 07/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Race: White