MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY INC. VERSACROSS LARGE 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 10/11/2023

Event Type  Injury  

Event Description

It was reported that a thrombus occurred.During a left atrial appendage closure (laac) procedure, a versacross large access kit was selected for use.The transseptal puncture was completed successfully.It was noted that there was a thrombus appeared on the sheath.A full dose of heparin was administered only after the puncture.The procedure was completed successfully, and no other patient complications or interventions were reported.The device is not expected to be returned for analysis.It was further informed that the patient was being treated for atrial fibrillation of the patient and bleedings.The physician believes the radio frequency puncture is much more thrombogenic and heparin should be use before and completed after.But at the same time he does not like to use heparin before the transseptal puncture.The procedure was not so long to measure act.The thrombus appeared just after the transseptal puncture.No medical intervention needed and was not kept hospitalized.It was further confirmed the thrombus was noted on the dilator.The watchman sheath was used after the thrombus appeared.

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 thrombus occurred.During a left atrial appendage closure (laac) procedure, a versacross large access kit was selected for use.The transseptal puncture was completed successfully.It was noted that there was a thrombus appeared on the dilator.A full dose of heparin was administered only after the puncture.The procedure was completed successfully, and no interventions reported.The device is not expected to be returned for analysis.It was further informed that the patient was being treated for atrial fibrillation of the patient and bleedings.The part and lot number of the device was not kept.The physician believes the radio frequency puncture is much more thrombogenic and heparin should be use before and completed after.But at the same time.He does not like to use heparin before the transseptal puncture.A full dose of heparin was administered only after the puncture.The thrombus appeared just after the transseptal puncture.No medical intervention needed and the patient was not kept hospitalized.It was further confirmed the thrombus was noted on the dilator.The watchman sheath was used after the thrombus appeared.It was further reported that the suspect medical device was an nrg rf transseptal kit, not the versacross large access kit.

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 LARGE 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: 18066747
• MDR Text Key: 327304838
• Report Number: 2124215-2023-61523
• Device Sequence Number: 1
• Product Code: DRE
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K073326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/20/2023
• 2 Devices were Involved in the Event: 1 2

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: 10/11/2023
• Initial Date FDA Received: 11/03/2023
• Supplement Dates Manufacturer Received: 11/06/2023
• Supplement Dates FDA Received: 11/20/2023
• 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