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

Lot Number VMFC120523

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 08/24/2023

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 will be filed.

Event Description

It has been reported that a versacross connect left atrial appendage closure (laac) access solution kit has been selected for use for a watchman procedure.During the procedure, the physician mentioned that the j-tip guidewire got stuck at the tip of the dilator as they attempted to withdraw it.The procedure was completed successfully using a different device (same model).No patient complications reported.Product is expected to return for analysis.

Manufacturer Narrative

It was further confirmed (14oct2023) that the device will not be returned for evaluation.The field b5 (describe event or problem) was updated.Thus, a supplemental medwatch will be filed.

Event Description

It has been reported that a versacross connect left atrial appendage closure (laac) access solution kit has been selected for use for a watchman procedure.During the procedure, the physician mentioned that the j-tip guidewire got stuck at the tip of the dilator as they attempted to withdraw it.It was also reported that the dilator tip was damaged.The procedure was completed successfully using a different device (same model).No patient complications reported.Product is expected to return for analysis.It was further confirmed that the device will not return for analysis and no further issues were noted.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 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: 17764650
• MDR Text Key: 323610267
• Report Number: 2124215-2023-50470
• 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: 11/06/2023

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 Number: VMFC120523
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/24/2023
• Initial Date FDA Received: 09/18/2023
• Supplement Dates Manufacturer Received: 10/14/2023
• Supplement Dates FDA Received: 11/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Male