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

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

Patient Problems Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 10/10/2023

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 during an atrial fibrillation ablation (a fib) procedure, a versacross connect access solution kit was selected for use.The case proceeded as usual; a radiofrequency (rf) ablation was used to touch up the right superior pulmonary vein.After about an hour of ablating, when the polarx cryoballoon and polarmap were withdrawn from the left atrium to the right atrium, the physician noticed a pericardial effusion due to a perforation via a non-boston scientific ice catheter.The effusion was posterior to left ventricle (lv) the patient was monitored for 20 minutes, and effusion did not grow.The appearance of the pe was significantly larger and more noticeable after the procedure.No difficulties or complications noted during the procedure.The perforation was only noticed at the very end of the case, but the physician believes it had already closed off because the effusion did not get any bigger at the end of the procedure.The transseptal was completed prior to significant pe and radio frequency was only applied once.No reason to believe that the versacross wire malfunctioned during the procedure, and no other issues were noted.The patient did not have a prior history of tsp.13,000 units of heparin was given at 8:19 and the tsp was done at 8:27 (act was 293 at 8:43).5000 units of heparin was given at 8:43 (atc was 405 at 9:07).A pericardiocentesis was not required and the procedure was completed.The patient fully recovered and was not admitted to hospital beyond standard of care.The device is not expected to be returned for analysis (disposed).In the physician's opinion, the versacross devices did not cause or contribute to the patient complication.The effusion did not grow while we watched it for the last 20 minutes of the procedure.It also became smaller and started to clot very quickly after protamine was administered.The physician believes that the perforation must have been very small.He believes it could have been the rv diagnostic catheter that was placed into the superior vena cava (svc) for phrenic nerve pacing.

• Brand Name: VERSACROSS CONNECT ACCESS SOLUTION FOR POLARSHEATH
• 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: 18081374
• MDR Text Key: 327476730
• Report Number: 2124215-2023-61033
• Device Sequence Number: 1
• Product Code: DRE
• UDI-Device Identifier: 00685447019008
• UDI-Public: 00685447019008
• 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: 11/06/2023

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: 10/10/2023
• Initial Date FDA Received: 11/06/2023
• 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