MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY INC. VERSACROSS ACCESS SOLUTION; CATHETER, SEPTOSTOMY

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Air Embolism (1697); Cardiac Arrest (1762); Hemorrhage/Bleeding (1888); High Blood Pressure/ Hypertension (1908); Cardiac Tamponade (2226); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 10/30/2023

Event Type  Death  

Event Description

It was reported that a patient death occurred.The procedure was cancelled.During a watchman procedure to treat atrial fibrillation (a fib), a versacross kit was selected for use.The physician expressed that the patient had complicated atypical anatomy and the transseptal puncture was performed with more difficulty than usual.When the versacross sheath was being exchanged to watchman sheath, the transseptal wire access was lost.Therefore, a second transseptal puncture was performed, and the versacross sheath was exchanged for watchman sheath.A non-boston scientific pigtail was used through watchman sheath to locate the left atrium appendage.Thus, the watchman sheath was advanced into the left atrial appendage (laa).Due to the transesophageal echocardiogram (tee) imaging quality, the physician was unable to determine to what depth the was had advanced into the laa.Contrast injection was used to assess the laa size and shape and the closure device was deployed.Anesthesiologist alerted the team of sudden pressure drop however concerns were focused on possible air embolism.Limited echo views initially did not suggest effusion.Code was initiated with chest compressions.Then, transesophageal echocardiogram (tte) identified a pericardial effusion and a pericardiocentesis was performed.Surgical intervention took place and a perforation was discovered in the left atrium.During manipulation of the heart, the laceration was unable to be closed.The laceration increased in size and attempts were made to suture and closed it were unsuccessful.The patient died of blood loss.As per the physician, possible due to patient history of anabolic steroids to treat past lymphoma.The device is not expected to be returned for analysis (disposed).The patient has medical history of lymphoma.In the physicians opinion, the watchman and versacross system caused the cardiac perforation which led to cardiac tamponade.

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 ACCESS SOLUTION
• Type of Device: CATHETER, SEPTOSTOMY
• 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: 18201934
• MDR Text Key: 328882923
• Report Number: 2124215-2023-63263
• Device Sequence Number: 1
• Product Code: DXF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150709
• 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: 11/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2023
• 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
• Date Manufacturer Received: 10/30/2023
• 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): Life Threatening; Death; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Race: White