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 Hematoma (1884); Perforation of Vessels (2135); Pericardial Effusion (3271)

Event Date 10/04/2023

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 vessel perforation and pericardial effusion were noted.During the transeptal crossing, the versacross rf wire grazed along the outer wall of the aorta, and it was believed that a small perforation occurred.However, the procedure continued, and the watchman device was implanted with no issues.The perforation self-sealed during procedure after several minutes, a hematoma was noted on outer wall of aorta and small pericardial effusion on the pericardial sack was noted as well (size.5).The patients' vitals were stable, no further intervention was needed, and the patient fully recovered.The patient was not admitted to hospital beyond standard care.The procedure was completed.The device is not expected to be returned for analysis (disposed).The patient was not on warfarin nor on antiplatelet drugs at this point.The patient was expected to be discharged (b)(6) 2023 (current status is unknown).A transesophageal echocardiogram (tee) was used to confirm perforation.The patient has lipomatous septum with small window.The transseptal puncture was completed prior to noticing the pe and radio frequency was only applied once.No reason to believe that the versacross devices malfunctioned during the procedure.The act therapeutic during the procedure was at 371 and at 300 after the procedure.In the physician's opinion, the device contributes to the patient complications, since when crossing the septum, the rf versacross wire made contact with the aortic wall when crossing into the left atrium, which could cause a small perforation on the outer wall of the aorta.

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation; however, a media was provided.Thus, a supplemental mdr to report will be filed (mdr aware date (b)(6)2023).The complaint is confirmed by the media provided in the complaint (pre-procedure and post-procedure aortic puncture).The cause is not determined as the device has not been returned to bsc for analysis.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 vessel perforation and pericardial effusion were noted.During the transeptal crossing, the versacross rf wire grazed along the outer wall of the aorta, and it was believed that a small perforation occurred.However, the procedure continued, and the watchman device was implanted with no issues.The perforation self-sealed during procedure after several minutes, a hematoma was noted on outer wall of aorta and small pericardial effusion on the pericardial sack was noted as well (size.5).The patients' vitals were stable, no further intervention was needed, and the patient fully recovered.The patient was not admitted to hospital beyond standard care.The procedure was completed.The device is not expected to be returned for analysis (disposed).The patient was not on warfarin nor on antiplatelet drugs at this point.The patient was expected to be discharged 10/06/2023 (current status is unknown).A transesophageal echocardiogram (tee) was used to confirm perforation.The patient has lipomatous septum with small window.The transseptal puncture was completed prior to noticing the pe and radio frequency was only applied once.No reason to believe that the versacross devices malfunctioned during the procedure.The act therapeutic during the procedure was at 371 and at 300 after the procedure.In the physician's opinion, the device contributes to the patient complications, since when crossing the septum, the rf versacross wire made contact with the aortic wall when crossing into the left atrium, which could cause a small perforation on the outer wall of the aorta.

• 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: 18048873
• MDR Text Key: 327086831
• Report Number: 2124215-2023-60345
• 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: 12/19/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/04/2023
• Initial Date FDA Received: 11/01/2023
• Supplement Dates Manufacturer Received: 12/12/2023
• Supplement Dates FDA Received: 12/19/2023
• 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): Life Threatening
• Patient Age: 83 YR
• Patient Sex: Female