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 Problems Low Blood Pressure/ Hypotension (1914); Ischemia (1942); Myocardial Infarction (1969)

Event Date 02/14/2024

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 a myocardial infarction / ischemia occurred.During a watchman left atrial appendage closure (laac) procedure to treat atrial fibrillation (a fib), a versacross large access kit was selected for use.After the groin access, the mechanical j-wire was inserted and it was noted the patient became unstable.The staff nurse also noted that the patients airway pressures were elevated and then became hypotensive.The implant physician decided to perform a diagnostic catheterization noting an unstable left anterior descending (lad) lesion.A lad stent was placed and once the patient was stabilized, the watchman procedure was completed.The device is not expected to be returned for analysis.It was further confirmed only the mechanical j-wire in the kit was introduced in the patient's groin- at the point when patient decompensated.There is no reason to believe that the wire was involved in his acute myocardial infarction.The patient had a known coronary artery disease, a history of prior transcatheter aortic valve replacement (tavr).In the physician's opinion, the versacross device did not malfunctioned or contributed to the patient condition.The patient was stabilized prior to making the decision to implant the watchman device.

• 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, 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: 18884928
• MDR Text Key: 337417673
• Report Number: 2124215-2024-14427
• 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
• Report Date: 03/12/2024

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: 02/14/2024
• Initial Date FDA Received: 03/12/2024
• 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: 78 YR
• Patient Sex: Male
• Patient Race: White