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

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

Patient Problem Pericardial Effusion (3271)

Event Date 05/13/2022

Event Type  Injury  

Event Description

It was reported that following transeptal puncture (tsp) with a veracross large assess device for a watchman procedure, the wire could not be seen in the left atrium (la).The wire was located with the device in the transverse sinus running along the aortic root.A pericardial effusion was noted, and a pericardial tap was performed.Further continuation of the watchman procedure was canceled.The patient was admitted beyond the standard of care and later fully recovered.

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.

Manufacturer Narrative

Additional information added to b5: describe event or problem.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 following transeptal puncture (tsp) with a veracross large assess device for a watchman procedure, the wire could not be seen in the left atrium (la).The wire was located with the device in the transverse sinus running along the aortic root.A pericardial effusion was noted, and a pericardial tap was performed.Further continuation of the watchman procedure was canceled.The patient was admitted beyond the standard of care and later fully recovered.It was further reported that they could not see the tent on the tsp, i did not see the wire in the left atrium.Two drops attempted; transesophageal echocardiography (tee) was used.Patient had no leads implanted.

Manufacturer Narrative

Correction to include f1001: absence of treatment f10/h6 code.The device has not been received for analysis; therefore, a failure analysis of the complaint device could not be completed.

Event Description

It was reported that following transeptal puncture (tsp) with a veracross large assess device for a watchman procedure, the wire could not be seen in the left atrium (la).The wire was located with the device in the transverse sinus running along the aortic root.A pericardial effusion was noted, and a pericardial tap was performed.Further continuation of the watchman procedure was canceled.The patient was admitted beyond the standard of care and later fully recovered.It was further reported that they could not see the tent on the tsp, i did not see the wire in the left atrium.Two drops attempted; transesophageal echocardiography (tee) was used.Patient had no leads implanted.

• Brand Name: VERSACROSS 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: 17584945
• MDR Text Key: 321546135
• Report Number: 2124215-2023-42269
• Device Sequence Number: 1
• Product Code: DRE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201288
• 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,Followup
• Report Date: 11/02/2023

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: 07/26/2023
• Initial Date FDA Received: 08/21/2023
• Supplement Dates Manufacturer Received: 08/29/2023; 10/10/2023
• Supplement Dates FDA Received: 08/31/2023; 11/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female