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U.S. Department of Health and Human Services

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

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BAYLIS MEDICAL COMPANY INC. VERSACROSS CONNECT LAAC ACCESS SOLUTION; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION Back to Search Results
Device Problems Difficult to Advance (2920); Positioning Problem (3009)
Patient Problems Cardiac Tamponade (2226); Pericardial Effusion (3271)
Event Date 01/16/2024
Event Type  Injury  
Event Description
It was reported that a pericardial effusion and cardiac tamponade occurred.During a watchman left atrial appendage closure (laac) procedure, a versacross connect kit was selected for use.The transseptal puncture was performed and watchman device was implanted successfully.Approximately six to seven hours post procedure, the patient developed a pericardial effusion and cardiac tamponade.Pericardiocentesis was performed to drain the effusion, and the patient was kept overnight for monitoring.One day post procedure, the physician informed that the drain would not pull any more fluid from the effusion site.The patient was expected to fully recover.The device is not expected to be returned for analysis.It was further confirmed that there was substantial difficulty in crossing the septum because of tortuous anatomy in the inferior vena cava (ivc) and getting the preferred angle on the septum was not possible so a more posterior than usual transseptal puncture was performed.The physician was concerned that this was the cause of the effusion simply because the effusion seemed to manifest many hours later, but he still considers it a possibility.There were multiple attempts required to track up / drop down into position on septum.No imaging issues noted.The wire had a clear tent but it was very posterior and looked to be through thicker tissue than the usual/ideal fossa ovalis.The physician felt that because obtaining even that suboptimal position was quite difficult, this was the best he could do and opted to cross despite being very posterior.Act was above 200 seconds.No malfunctions noted with versacross device.
 
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.
 
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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, qc 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 Key18667918
MDR Text Key334950787
Report Number2124215-2024-06970
Device Sequence Number1
Product Code DRE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K220414
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 02/08/2024
1 Device was Involved in the Event
Date FDA Received02/08/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/17/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unknown
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