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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 VMFE120523
Device Problems Fracture (1260); Difficult to Remove (1528); Defective Device (2588); Device-Device Incompatibility (2919); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/14/2023
Event Type  malfunction  
Event Description
It was reported that a versacross connect system was selected for use during a watchman case.The mechanical guidewire was inserted into the right femoral vein (from a non-boston scientific access sheath) and advanced into the superior vena cava.The watchman sheath and connect dilator were inserted over the mechanical guidewire into the right atrium, and the mechanical guidewire became tangled on itself.The physician tried to untangle it, unsuccessfully, thus it had to remove the whole system from the patient body (in one piece), since the mechanical guidewire was stuck inside the dilator.A knot formed on the mechanical guidewire, and it also unraveled (fractured and frayed).Then, outside of the patient body, the physician had to cut the mechanical guidewire to remove it from the dilator.Hence, to complete the case, a new versacross connect system was opened.No patient complication was reported.The procedure was completed successfully.The device is not expected to be returned for analysis.Additionally, a protrusion issue was noticed during the was sheath and versacross dilator drop down on the system.
 
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 system was selected for use during a watchman case.The mechanical guidewire was inserted into the right femoral vein (from a non-boston scientific access sheath) and advanced into the superior vena cava.The watchman sheath and connect dilator were inserted over the mechanical guidewire into the right atrium, and the mechanical guidewire became tangled on itself.The physician tried to untangle it, unsuccessfully, thus it had to remove the whole system from the patient body (in one piece), since the mechanical guidewire was stuck inside the dilator.A knot formed on the mechanical guidewire, and it also unraveled (fractured and frayed).Then, outside of the patient body, the physician had to cut the mechanical guidewire to remove it from the dilator.Hence, to complete the case, a new versacross connect system was opened.No patient complication was reported.The procedure was completed successfully.The device is not expected to be returned for analysis.Additionally, a protrusion issue was noticed during the was sheath and versacross dilator drop down on the system.
 
Manufacturer Narrative
This is supplemental mdr to report the investigation results based on the picture provided.As indicated, the device was not returned; however pictures were provided.The images show that the guidewire was damaged/defective and that it would have gotten stuck in the dilator as the outer coil was stretched and the guidewire was deformed.The reported allegations for damaged/defective and stuck were deemed failure confirmed.For the other issues, the reported allegations cannot be confirmed as the devices were not returned and the images were not sufficient to determine if the other listed device codes occurred.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 Key17686346
MDR Text Key322715176
Report Number2124215-2023-44784
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 12/11/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Lot NumberVMFE120523
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/14/2023
Initial Date FDA Received09/05/2023
Supplement Dates Manufacturer Received11/20/2023
Supplement Dates FDA Received12/11/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/15/2023
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age84 YR
Patient SexFemale
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