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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 VMFC120523
Device Problems Device-Device Incompatibility (2919); Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/29/2023
Event Type  malfunction  
Event Description
It has been reported that a versacross connect laac access solution kit has been selected for use for a left atrial appendage closure (laac) procedure in order to treat a case of atrial fibrillation (a fib).During the procedure, the physician mentioned that the guidewire got stuck in the dilator as they attempted to insert it over the wire.The guidewire was inserted into the superior vena cava (svc) with no issue, but the dilator became stuck as they advanced it over the guidewire, before entering the patient's body.The physician was eventually able to remove the dilator from the wire using an excessive force, and then switch to the versacross pigtail wire to complete the procedure, different device (different model).No patient complications reported.The device is expected to return for analysis.
 
Manufacturer Narrative
The device has been received at boston scientific's post market laboratory where it is awaiting analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental will be filed.
 
Manufacturer Narrative
This is a supplemental mdr to report the investigation results (mdr aware date (b)(6) 2024).The device was returned for analysis.Analysis of the device found that no notable defect or irregularities are present on the dilator.However, the mechanical guidewire featured 2 opposing kinks at 40cm and 50cm respectively from the proximal end.In addition, minor coil stacking is present at the distal tip of the guidewire, along with coating loss seen in proximity of the kinked sections.Sections f10 (device codes), f10 (component codes), h6 (device codes), h6 (component codes), h6 (evaluation method codes) and h6 (evaluation conclusion codes) have been updated.This product is part of the (b)(4) epflex guidewire obstruction advisory commencement advisory for the j-tipped mechanical guidewire.
 
Event Description
It has been reported that a versacross connect laac access solution kit has been selected for use for a left atrial appendage closure (laac) procedure in order to treat a case of atrial fibrillation (a fib).During the procedure, the physician mentioned that the guidewire got stuck in the dilator as they attempted to insert it over the wire.The guidewire was inserted into the superior vena cava (svc) with no issue, but the dilator became stuck as they advanced it over the guidewire, before entering the patient's body.The physician was eventually able to remove the dilator from the wire using an excessive force, and then switch to the versacross pigtail wire to complete the procedure, different device (different model).No patient complications reported.The device is expected to return for analysis.
 
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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 Key17819636
MDR Text Key324289057
Report Number2124215-2023-52623
Device Sequence Number1
Product Code DRE
UDI-Device Identifier00685447012573
UDI-Public00685447012573
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 01/31/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/26/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Lot NumberVMFC120523
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/18/2023
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/08/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/15/2023
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age79 YR
Patient SexMale
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