MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY INC. VERSACROSS CONNECT LAAC ACCESS SOLUTION; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Lot Number VMFB290523

Device Problems 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 10/03/2023

Event Type  malfunction  

Event Description

It was reported that during a watchman implant procedure to treat stroke prevention, a versacross connect kit was selected for use.It was noted that the mechanical guidewire was stuck in dilator when femoral vein access was gained and hence to resolve the issue a new kit was used.The procedure was completed successfully, and no patient complications occurred.The device return is available.There were no visible issues with the mechanical guidewire upon removal from the packaging.Patient anatomy was tortuous.There was possible some force used but not enough for the wire to separate.The wire could not be withdrawn and removed from the dilator.The wire was split.Patient had no leads.This product is part of the 97072033-fa epflex guidewire obstruction advisory commencement advisory for the j-tipped mechanical guidewires.

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.

Manufacturer Narrative

Supplemental mdr is submitted to report investigation results.Mdr aware date 12feb2024.The device was returned for analysis.During analysis of the device, from visual inspection, it was noted the mechanical guidewire was not removed from the dilator.There were multiple kinks at both the distal and proximal end.The guidewire was unraveled at the distal end.X-ray image shows the radio opaque coil of the dilator being pulled into the lumen.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.Coil stacking was present from the distal tip of the guidewire.A calibrated pin gage used to measure the dilator tip inside diameter and the pin gage was not able to pass the radio opaque coil.The dilator tip was radially deformed near the radio opaque coil location.A wire pass test was performed using a reference guidewire which was not able to pass at the radio opaque coil location.The x-ray image was evident that this could be caused by the displaced radio opaque coil being pulled into the lumen of the dilator by the passing guidewire.The reported allegation was confirmed.This product is part of the 97072033-fa epflex guidewire obstruction advisory commencement advisory for the j-tipped mechanical guidewires.

Event Description

It was reported that during a watchman implant procedure to treat stroke prevention, a versacross connect kit was selected for use.It was noted that the mechanical guidewire was stuck in dilator when femoral vein access was gained and hence to resolve the issue a new kit was used.The procedure was completed successfully, and no patient complications occurred.The device return is available.There were no visible issues with the mechanical guidewire upon removal from the packaging.Patient anatomy was tortuous.There was possible some force used but not enough for the wire to separate.The wire could not be withdrawn and removed from the dilator.The wire was split.Patient had no leads.This product is part of the 97072033-fa epflex guidewire obstruction advisory commencement advisory for the j-tipped mechanical guidewires.

• 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, qc 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 Key: 18048388
• MDR Text Key: 327081290
• Report Number: 2124215-2023-59755
• Device Sequence Number: 1
• Product Code: DRE
• UDI-Device Identifier: 00685447012573
• UDI-Public: 00685447012573
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K220414
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: VMFB290523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 78 KG
• Patient Race: White