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

Lot Number VMFK211222

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 03/21/2023

Event Type  Injury  

Event Description

It was reported that thrombosis occurred during procedure with watchman access system and versacross connect laac access system.A left atrial appendage (laa) closure procedure was being performed.A watchman fxd access system (was) was positioned toward the mitral annulus.The physician was inserting the pigtail catheter and as it came out of the was, discovered that the cheater was on the pigtail catheter.The pigtail catheter was removed, the cheater was taken off, and the pigtail catheter was re-inserted.The pigtail catheter was positioned into the laa and the was was advanced just past the laa ostium.It was then noticed that a clot or tissue was on the mitral valve annulus.The pigtail catheter was removed and the aspiration through the was attempted but unsuccessful.The procedure was aborted and patient was discharged the same day.It was further reported that the patient was administered heparin during the procedure and the initial activated clotting time (act) was taken during the trans-septal puncture and recorded at 299 seconds.The suspected thrombus was identified via transesophageal echocardiogram (tee) and was noted to be grounded to the mitral annulus and mobile.The suspected thrombus was not confirmed to have resolved during the procedure.In response to the event, the patient was switched from dual-antiplatelet therapy to eliquis and is expected to return 6 weeks later for a repeat tee.If the suspected thrombus has resolved, the watchman implant procedure will be reattempted.(b)(6) 2023: patient did not have any coagulopathies."cheater" is referring to the plastic tube that comes with pigtail catheters to straighten out the pigtail part so the physician can easily introduce it into the sheath.

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.

• 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: 17686300
• MDR Text Key: 322698047
• Report Number: 2124215-2023-48113
• Device Sequence Number: 1
• Product Code: DRE
• UDI-Device Identifier: 00685447012597
• UDI-Public: 00685447012597
• 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
• Report Date: 09/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: VMFK211222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2023
• Initial Date FDA Received: 09/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female