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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
Lot Number VMFE061123
Device Problems Material Fragmentation (1261); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/13/2024
Event Type  malfunction  
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 has been reported that a versacross connect access solution kit was selected for use during a watchman procedure.During the procedure, the physician mentioned that they used the proximal hub on the versacross dilator to check the right atrial pressure.While the device was in inside the patient, when it was attempted to disconnect the hub from the manifold, it broke off.Thus, a new kit was then opened, and the procedure was completed successfully.No patient complications were reported.Product is not expected to return for analysis (discarded).No issues were noted to the device once removed from its package.However, it was mentioned that one factor that may have caused the damage is that a non-boston scientific syringe was screwed to the hub of the dilator on too tightly, and while it was tried to unscrew the syringe from the dilator hub, that is when it broke off.
 
Manufacturer Narrative
The device was not returned for analysis.However, based on the media provided, the reported allegation was confirmed during analysis.Also, the field e1 (initial reporter address 1) was updated.Thus, a supplemental mdr is being filed (mdr aware date is (b)(6) 2024).If there is any further relevant information obtained, a supplemental medwatch will be filed.
 
Event Description
It has been reported that a versacross connect access solution kit was selected for use during a watchman procedure.During the procedure, the physician mentioned that they used the proximal hub on the versacross dilator to check the right atrial pressure.While the device was in inside the patient, when it was attempted to disconnect the hub from the manifold, it broke off.Thus, a new kit was then opened, and the procedure was completed successfully.No patient complications were reported.Product is not expected to return for analysis (discarded).No issues were noted to the device once removed from its package.However, it was mentioned that one factor that may have caused the damage is that a non-boston scientific syringe was screwed to the hub of the dilator on too tightly, and while it was tried to unscrew the syringe from the dilator hub, that is when it broke off.
 
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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 Key19014775
MDR Text Key339092182
Report Number2124215-2024-19500
Device Sequence Number1
Product Code DRE
UDI-Device Identifier00685447012597
UDI-Public00685447012597
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,Followup
Report Date 04/26/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Lot NumberVMFE061123
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/08/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/08/2023
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Patient SexMale
Patient RaceWhite
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