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

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

Patient Problem Thrombosis/Thrombus (4440)

Event Date 01/29/2024

Event Type  Injury  

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 thrombosis occurred.During a left atrial appendage closure (laac) procedure, a versacross connect kit was selected for use.Heparin was administered before and after transseptal puncture (5,000 units before and immediately after tsp).Patient also was maintained on warfarin with a therapeutic inr on day of procedure (inr 2.5).Transseptal puncture was performed successfully with one successful constant radio frequency application at one second.The watchman sheath was advanced and while advancing the wire near the left superior pulmonary vein (lspv), a mobile echogenic density was seen connected to the tip of the sheath.It is believed that this density was likely a thrombus.Aspiration using sheath attempted and echogenic density seemed to resolved.The partial thromboplastin time (ptt) was checked and the physician proceeded with the procedure.The patient was fully recovered and discharged.The device is not expected to be returned for analysis.It as further confirmed that the physicians were unsure what contributed to the thrombosis but they hypothesized that maybe the thrombosis was gathered into versacross connect tsp system/sheath while going through the inferior vena cava (ivc), but at at that time the thrombus was not visualized in the right atrium and did not suspected thrombus until moved into the left atrium.Then once they crossed into the left atrium and exchanged the wire for the non-boston scientific pigtail catheter then the thrombosis moved to the tip of sheath and became visualized on transesophageal echocardiogram (tee).

• 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: 18740031
• MDR Text Key: 335766798
• Report Number: 2124215-2024-09290
• Device Sequence Number: 1
• Product Code: DRE
• 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: 02/20/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/29/2024
• Initial Date FDA Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 116 KG