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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 VMFD240323
Device Problems Difficult to Remove (1528); Defective Device (2588); Component or Accessory Incompatibility (2897); Device-Device Incompatibility (2919); Material Deformation (2976); Material Integrity Problem (2978); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/22/2023
Event Type  malfunction  
Event Description
It was reported that a versacross connect kit was selected for use during a watchman procedure.The versacross connect was inserted into the body, and the mechanical guidewire was used initially and placed in the right atrium trough the watchman fxd double curve sheath with versacross connect dilator.The mechanical guidewire seemingly inserted correctly, with just a touch of difficulty.Then, it was tried to remove the mechanical guidewire and some resistance was noticed when removing the mechanical guidewire from the non-boston scientific introducer sheath.Thus, fluoro was used and it was noted that the mechanical guidewire tip got caught on the tip of dilator.Thus, the mechanical guidewire was advanced a little bit more and the tip of the mechanical guidewire came free from the dilator (seemed stuck), and then was removed from the patient body along with the dilator.Thus, it was noticed that the mechanical guidewire was bent, but was fully intact.The dilator was also inspected upon removal and was also intact.The insulation of the mechanical guidewire was stripping off at distal on the wire.On the side, it was reported that a very small piece of the mechanical guidewire insulation may have been missing from the tip area of the mechanical guidewire.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.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 kit was selected for use during a watchman procedure.The versacross connect was inserted into the body, and the mechanical guidewire was used initially and placed in the right atrium trough the watchman fxd double curve sheath with versacross connect dilator.The mechanical guidewire seemingly inserted correctly, with just a touch of difficulty.Then, it was tried to remove the mechanical guidewire and some resistance was noticed when removing the mechanical guidewire from the non-boston scientific introducer sheath.Thus, fluoro was used and it was noted that the mechanical guidewire tip got caught on the tip of dilator.Thus, the mechanical guidewire was advanced a little bit more and the tip of the mechanical guidewire came free from the dilator (seemed stuck), and then was removed from the patient body along with the dilator.Thus, it was noticed that the mechanical guidewire was bent, but was fully intact.The dilator was also inspected upon removal and was also intact.The insulation of the mechanical guidewire was stripping off at distal on the wire.On the side, it was reported that a very small piece of the mechanical guidewire insulation may have been missing from the tip area of the mechanical guidewire.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 returned mechanical guidewire was analyzed.The mechanical guidewire was returned in one piece.There were no fractures noticed and the core wire was intact.Visual evaluation also noted abnormal curves and bends at the distal end.There was no evidence of damage to the guidewire body or proximal end of the wire.The reported allegation was confirmed.There was outer diameter and high magnification imaging test conducted on the returned guidewire.The outer diameter measurement test revealed that the outer diameter was within drawing specifications and the high magnification imaging measurement test observed some coating loss and also discovered abnormal bend at the distal end of the wire.Detailed imaging of the guidewire also indicated coil overlap and coil spacing at the kink location.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 Key17774112
MDR Text Key323734864
Report Number2124215-2023-49273
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 11/27/2023
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 NumberVMFD240323
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/05/2023
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/22/2023
Initial Date FDA Received09/19/2023
Supplement Dates Manufacturer Received10/30/2023
Supplement Dates FDA Received11/27/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/28/2023
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age69 YR
Patient SexMale
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