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

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemothorax (1896); Low Blood Pressure/ Hypotension (1914); Pleural Effusion (2010)
Date of Event	08/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A hypotension and a pleural effusion occurred.It was reported that a versacross connect laac access solution was selected for use for a watchman left atrial appendage closure (laac) procedure.During the procedure, the physician guided the versacross rf wire to the superior vena cava (svc) as normal, followed up with the versacross dilator and the watchman fxd double curve sheath.Transseptal puncture was performed standard with no issues.As the watchman device was being prepped on the table, the patient's blood pressure began dropping to 35/25, therefore, the anesthesiologist gave medication to bring the blood pressure up and a bolus of fluids.A sweep for a pericardial effusion was performed multiple times over the course of 5-10 mins, and none was found.A groin art line was inserted and checked for bp as well and it was consistent, by this time the bp had come up to 120/80 and the procedure was finished as normal with one deployment of the flx pro 27mm device.Pass criteria were evaluated and met, and the device was released.Watchman delivery and access system were then removed, and bp was not stable again.The physician then performed a venogram of the ivc and didn't see anything concerning.They then proceeded to perform an x-ray over the chest and noticed the right lung decompressed away from the lateral side of the ribs.At this point, they removed 2l of blood from the patient's plueral space and placed a chest tube.The physician then performed multiple venograms of the lungs and various areas of the venous system and didn't find any leaks.At this point in time, they left the chest tube with the bleed from the lungs slowing and decided to take the patient to intensive care unit (icu) to recover.The patient is still in the hospital, but fully alert and doing much better despite still having a chest tube in place.Their kidney function is recovered, and they are neurologically intact.Product is not expected to return for analysis as it was disposed of at the facility.The physician does not believe that either of the versacross devices malfunctioned during the procedure nor contributed to the ae.Patient has not yet been discharged due to urine output issues.No other issues were reported.
Additional 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 or Problem Description
A hypotension and a pleural effusion occurred.It was reported that a versacross connect laac access solution was selected for use for a watchman left atrial appendage closure (laac) procedure.During the procedure, the physician guided the versacross rf wire to the superior vena cava (svc) as normal, followed up with the versacross dilator and the watchman fxd double curve sheath.Transseptal puncture was performed standard with no issues.As the watchman device was being prepped on the table, the patient's blood pressure began dropping to 35/25, therefore, the anesthesiologist gave medication to bring the blood pressure up and a bolus of fluids.A sweep for a pericardial effusion was performed multiple times over the course of 5-10 mins, and none was found.A groin art line was inserted and checked for bp as well and it was consistent, by this time the bp had come up to 120/80 and the procedure was finished as normal with one deployment of the flx pro 27mm device.Pass criteria were evaluated and met, and the device was released.Watchman delivery and access system were then removed, and bp was not stable again.The physician then performed a venogram of the ivc and didn't see anything concerning.They then proceeded to perform an x-ray over the chest and noticed the right lung decompressed away from the lateral side of the ribs.At this point, they removed 2l of blood from the patients plueral space and placed a chest tube.The physician then performed multiple venograms of the lungs and various areas of the venous system and didn't find any leaks.At this point in time, they left the chest tube with the bleed from the lungs slowing and decided to take the patient to intensive care unit (icu) to recover.The patient is still in the hospital, but fully alert and doing much better despite still having a chest tube in place.Their kidney function is recovered, and they are neurologically intact.Product is not expected to return for analysis as it was disposed of at the facility.The physician does not believe that either of the versacross devices malfunctioned during the procedure nor contributed to the ae.Patient has not yet been discharged due to urine output issues.No other issues were reported.It was further confirmed that the patient had an hemothorax.
Additional 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 or Problem Description
A hypotension and a pleural effusion occurred.It was reported that a versacross connect laac access solution was selected for use for a watchman left atrial appendage closure (laac) procedure.During the procedure, the physician guided the versacross rf wire to the superior vena cava (svc) as normal, followed up with the versacross dilator and the watchman fxd double curve sheath.Transseptal puncture was performed standard with no issues.As the watchman device was being prepped on the table, the patient's blood pressure began dropping to 35/25, therefore, the anesthesiologist gave medication to bring the blood pressure up and a bolus of fluids.A sweep for a pericardial effusion was performed multiple times over the course of 5-10 mins, and none was found.A groin art line was inserted and checked for bp as well and it was consistent, by this time the bp had come up to 120/80 and the procedure was finished as normal with one deployment of the flx pro 27mm device.Pass criteria were evaluated and met, and the device was released.Watchman delivery and access system were then removed, and bp was not stable again.The physician then performed a venogram of the ivc and didn't see anything concerning.They then proceeded to perform an x-ray over the chest and noticed the right lung decompressed away from the lateral side of the ribs.At this point, they removed 2l of blood from the patients plueral space and placed a chest tube.The physician then performed multiple venograms of the lungs and various areas of the venous system and didn't find any leaks.At this point in time, they left the chest tube with the bleed from the lungs slowing and decided to take the patient to intensive care unit (icu) to recover.The patient is still in the hospital, but fully alert and doing much better despite still having a chest tube in place.Their kidney function is recovered, and they are neurologically intact.Product is not expected to return for analysis as it was disposed of at the facility.The physician does not believe that either of the versacross devices malfunctioned during the procedure nor contributed to the ae.Patient has not yet been discharged due to urine output issues.No other issues were reported.It was further confirmed that the patient had an hemothorax.It has been further reported that the patient was successfully discharged.
Additional Manufacturer Narrative
Due to additional information received, the field b5 (describe event or problem) 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.

• Brand Name: VERSACROSS CONNECT LAAC ACCESS SOLUTION
• Common Device Name: CATHETER, SEPTOSTOMY
• 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: angela hinkley ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 20135828
• Report Number: 2124215-2024-55215
• Device Sequence Number: 20638443
• Product Code: DXF
• UDI-Device Identifier: 00685447012573
• UDI-Public: 00685447012573
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K150709
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/07/2024

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
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2024
• Supplement Date Received by Manufacturer: 09/06/2024; 09/25/2024
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 09/27/2024; 10/07/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Life Threatening
• Patient Age: 75 YR
• Patient Sex: Female