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 09/26/2023

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 versacross connect was selected for use during a watchman procedure.No heparin was given to the patient prior to the procedure.A transseptal puncture was completed, a non-boston scientific pigtail catheter (cook) was advanced on the versacross rf wire and the versacross rf wire was removed.Then, a full dose of heparin was given to the patient, and at the same time a thrombus was noticed on the non-boston scientific pigtail catheter.Therefore, the physician chose to remove the non-boston scientific pigtail catheter, flush/clean it, re-inserted it, the fxd curve sheath was aspirated, procedure continued and then was completed.Only one radio frequency was applied in the procedure.No difficulties with completing the transseptal were reported.The generator rf setting was at 1:1.It was also reported that it was the first time that the physician using versa cross connect, and his protocol was to give heparin after transseptal.It seems that the physician did not believe that the versacross devices had contributed to the clot exactly, however the speed at which it got him transeptal without the need to exchange sheaths and give heparin time to work was what caused it.There had been no act drawn or heparin given prior to the procedure.No issues with the versacross devices were reported.The devices are not expected to be returned for analysis (disposed).The imagining used was 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 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: 17985363
• MDR Text Key: 326271649
• Report Number: 2124215-2023-58283
• 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: 10/23/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2023
• Initial Date FDA Received: 10/23/2023
• 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): Other
• Patient Age: 82 YR
• Patient Sex: Male