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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pain (1994)
Event Date 10/05/2023
Event Type  Injury  
Event Description
It was reported that a versacross connect was selected for use during a watchman procedure.Started watchman case and not a good trajectory for the wm was noted, then it was decided to go transseptal again.While using intracardiac echocardiography (ice) only, the physician liked where he was at and took the transseptal.It was mentioned that it was not possible to see proper tenting on the fossa; upon inserting the versacross rf wire it was noticed that the wire went straight up towards 12 o'clock and had an "s" shape on fluoro.The patient, who was under moderate sedation, said that he felt a pain, an 8/10 and he was given medication to let the pain go away.Then, it went transseptal again while being able to see tenting and got the device to land properly.No other patient complications were reported.No other issues were noted.The procedure was completed.The device is not expected to be returned for analysis.The patient was fully recovered and discharged.The patient was not admitted to hospital beyond standard of care.
 
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.
 
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 was selected for use during a watchman procedure.Started watchman case and not a good trajectory for the wm was noted, then it was decided to go transseptal again.While using intracardiac echocardiography (ice) only, the physician liked where he was at and took the transseptal.It was mentioned that it was not possible to see proper tenting on the fossa; upon inserting the versacross rf wire it was noticed that the wire went straight up towards 12 oclock and had an "s" shape on fluoro.The patient, who was under moderate sedation, said that he felt a pain, an 8/10 and he was given medication to let the pain go away.Then, it went transseptal again while being able to see tenting and got the device to land properly.No other patient complications were reported.No other issues were noted.The procedure was completed.The device is not expected to be returned for analysis.The patient was fully recovered and discharged.The patient was not admitted to hospital beyond standard of care.It was further reported ((b)(6) 2023) that there were two transseptal (tsp) punctures done in the case, the first one with a versacross fixed kit and the second one with a versacross access.The first kit was swapped due to bad trajectory for the watchman device.On the second transseptal, the rf was delivered, and versacross rf wire was inserted, no sheath was pushed across (therefore not making puncture bigger).Thus, the physician gave medication to the patient to subside the pain.Then, the versacross rf wire was pulled back and went tsp again.The physician went tsp without seeing proper tent with the tsp system.There was an improper visualization of tent on ice with the second kit.No other issues were noted.Devices are not returning for investigation.
 
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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 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 Key18079134
MDR Text Key327483986
Report Number2124215-2023-61145
Device Sequence Number1
Product Code DRE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K183655
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,Followup
Report Date 11/29/2023
2 Devices were Involved in the Event: 1   2  
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 Not provided
Initial Date FDA Received11/06/2023
Supplement Dates Manufacturer Received11/07/2023
Supplement Dates FDA Received11/29/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
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