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

Lot Number VMFB050523

Device Problems Defective Device (2588); Detachment of Device or Device Component (2907); Difficult to Open or Remove Packaging Material (2922); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/26/2023

Event Type  malfunction  

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 access solution was selected for use during a laac.Prior to going transseptal, when attempting to remove a tightly screwed on syringe from the dilator hub, the dilator hub completely snapped off (completely broke off from the attachment point to the sheath), but the hub itself was still intact.Thus, a new kit was opened, and procedure was completed successfully.No patient complications were reported.The device is not expected to be returned for analysis.It was mentioned that it was difficult to get the device out of the packaging.

Event Description

It was reported that a versacross connect access solution was selected for use during a laac.Prior to going transseptal, when attempting to remove a tightly screwed on syringe from the dilator hub, the dilator hub completely snapped off (completely broke off from the attachment point to the sheath), but the hub itself was still intact.Thus, a new kit was opened, and procedure was completed successfully.No patient complications were reported.The device is not expected to be returned for analysis.It was mentioned that it was difficult to get the device out of the packaging.On 28sep2023, has been confirmed that the luer connection is broken off, from the handle portion of dilator, not the hub.

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation.The fields b5 - describe event or problem and f10 & h6 (device codes) were updated, thus the supplemental report will be filed.If there is any further relevant information obtained, a new supplemental medwatch will be filed.

• 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: 17565266
• MDR Text Key: 321377661
• Report Number: 2124215-2023-43645
• 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: 10/24/2023

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: VMFB050523
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/26/2023
• Initial Date FDA Received: 08/17/2023
• Supplement Dates Manufacturer Received: 09/28/2023
• Supplement Dates FDA Received: 10/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1