MAUDE Adverse Event Report: BAYLIS MEDICALE CIE INC VERSACROSS CONNECT LAAC ACCESS SOLUTION; CATHETER, SEPTOSTOMY

Model Number	VXAK0003
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	07/10/2024
Type of Reportable Event	Serious Injury
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.Detailed product information was not provided to bsc.A good faith effort to obtain the information is in progress, but it was not available yet.
Event or Problem Description
It was reported that pericardial effusion (pe) occurred.A left atrial appendage (laa) closure procedure was being performed.Venous access was obtained and transseptal puncture (tsp) was performed.A watchman flx pro closure device and delivery system (wd) was advanced and positioned at the laa then subsequently deployed and implanted.The procedure was concluded.During the same day of the index procedure, a pe was noted.According to the physicians, the pe was due to attempted tsp.No further details were reported.It was further reported the closure device was a 27mm watchman flx pro.The patient was enrolled into the heal-laa study on (b)(6) 2024 and index procedure was performed on the same day.Prior to the procedure, heparin was administered.A watchman trusteer access system was also used in the procedure.The pe was noted to be caused by the procedure on the same day of the index procedure.The pe noted on transesophageal echocardiogram imaging (tee) was 11 mm in size.The patient started taking aspirin and clopidogrel medications the same day of the index procedure and was subsequently discharged the following day.After 11 days post being discharged home, the patient was discontinued on clopidogrel due to side effects and restarted 3 days later.Later, both aspirin and clopidogrel medications were discontinued.The patient then presented for the 45 day routine follow up post index procedure, and tee imaging revealed the same pe from the index procedure was now noted to be 10mm.No further details were reported.It was further reported that a versacross connect (vcc) transseptal system was used with the watchman trusteer access system (was) in order to complete transseptal puncture (tsp).There was difficulty in obtaining tsp due to the patients prominent eustachian valve and rotation of the heart.According to the physician's it is likely the pe occurred with the versacross rf wire when it was in the right atrial appendage.The intraoperative tee performed did reveal a trace baseline effusion.Although the lowest hemoglobin and hematocrit level associated with the event was 14.2 g/dl and 42.7 % respectively, no transfusion was performed.
Additional Manufacturer Narrative
Due to additional information received, the fields b5 (describe event or problem), d4 (model number, catalog number and unique identifier (udi) #) were 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 or Problem Description
It was reported that pericardial effusion (pe) occurred.A left atrial appendage (laa) closure procedure was being performed.Venous access was obtained and transseptal puncture (tsp) was performed.A watchman flx pro closure device and delivery system (wd) was advanced and positioned at the laa then subsequently deployed and implanted.The procedure was concluded.During the same day of the index procedure, a pe was noted.According to the physicians, the pe was due to attempted tsp.No further details were reported.It was further reported the closure device was a 27mm watchman flx pro.The patient was enrolled into the heal-laa study on (b)(6) 2024 and index procedure was performed on the same day.Prior to the procedure, heparin was administered.A watchman trusteer access system was also used in the procedure.The pe was noted to be caused by the procedure on the same day of the index procedure.The pe noted on transesophageal echocardiogram imaging (tee) was 11 mm in size.The patient started taking aspirin and clopidogrel medications the same day of the index procedure and was subsequently discharged the following day.After 11 days post being discharged home, the patient was discontinued on clopidogrel due to side effects and restarted 3 days later.Later, both aspirin and clopidogrel medications were discontinued.The patient then presented for the 45 day routine follow up post index procedure, and tee imaging revealed the same pe from the index procedure was now noted to be 10mm.No further details were reported.It was further reported that a versacross connect (vcc) transseptal system was used with the watchman trusteer access system (was) in order to complete transseptal puncture (tsp).There was difficulty in obtaining tsp due to the patients prominent eustachian valve and rotation of the heart.According to the physicians it is likely the pe occurred with the versacross rf wire when it was in the right atrial appendage.The intraoperative tee performed did reveal a trace baseline effusion.Although the lowest hemoglobin and hematocrit level associated with the event was 14.2 g/dl and 42.7 % respectively, no transfusion was performed.It was further reported that the product use in this case was (b)(4).There was no malfunction noted with versacross devices, just tough anatomy.

• Brand Name: VERSACROSS CONNECT LAAC ACCESS SOLUTION
• Common Device Name: CATHETER, SEPTOSTOMY
• Manufacturer (Section D): BAYLIS MEDICALE CIE 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: 20558660
• Report Number: 2124215-2024-67771
• Device Sequence Number: 15698144
• Product Code: DXF
• UDI-Device Identifier: 00685447018346
• UDI-Public: 00685447018346
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2024

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
• Device Model Number: VXAK0003
• Device Catalogue Number: VXAK0003
• 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: 10/11/2024
• Supplement Date Received by Manufacturer: 11/13/2024
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 11/14/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male