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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 VMFC140723
Device Problems Defective Device (2588); Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/04/2023
Event Type  malfunction  
Manufacturer Narrative
The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
 
Event Description
It was reported that a versacross connect access solution was selected for use during a left atrium appendage implant.It was noted that the mechanical guidewire has a coating issue.It looks like it was shredded.No patient complications were reported.The procedure was completed successfully.The device is expected to be returned for analysis.No other issues were noted.
 
Event Description
It was reported that a versacross connect access solution was selected for use during a left atrium appendage implant.It was noted that the mechanical guidewire has a coating issue.It looks like it was shredded.No patient complications were reported.The procedure was completed successfully.The device is expected to be returned for analysis.No other issues were noted.
 
Manufacturer Narrative
The device has not been received for analysis.This is supplemental mdr to report investigation results (mdr aware date 15feb2024).Analysis of the device found that the mgw (mechanical guidewire) has unraveled at the distal end as exemplified by the loose distal tip coil which did not show the j shape tip and the stretched out coil rendering the wire core visible.Additionally, it was noted that the guidewire's unravelling is caused at the distal j tip.There are no notable kinks along the guidewire proximal to the floppy distal tip.Wire outer diameter measurements were taken with passing results compared to the drawing specifications.From vhx imaging, it was noted a minor coil stacking is present at the distal tip of the mgw.Also, the unraveling caused by the core wire fracture occurs at a critical location in terms of stress resistance and the fracture site shoes sing of necking which points to a ductile failure.Therefore, there is no sign of irregularities nor material quality concern.The reported allegations are confirmed.This product is part of the 97072033-fa epflex guidewire obstruction advisory commencement advisory for the j-tipped mechanical guidewires.
 
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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 Key18352911
MDR Text Key331073974
Report Number2124215-2023-69688
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 03/08/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Lot NumberVMFC140723
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/15/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/20/2023
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
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