MAUDE Adverse Event Report: BOSTON SCIENTIFIC DE COSTA RICA S.R.L. POLARSHEATH

Device Problem Leak/Splash (1354)

Patient Problems Aspiration/Inhalation (1725); Non specific EKG/ECG Changes (1817); Cardiac Tamponade (2226); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 04/19/2022

Event Type  Injury  

Manufacturer Narrative

The device is not expected to be returned for analysis.If the complaint device is received, and upon completion of the failure analysis, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported that during a cryoablation procedure involving a polarx, polarsheath, and polarmap, ablation of the left pulmonary veins (pv) was performed without issues.When doing the maneuver to go towards the right pvs, it was difficult to insert the polarmap in the pvs.The physician tried moving the catheters back to the left side.That is when he realized he was not in the left atrium, but in the right side of the heart.Possibly the infundibulum or the pulmonary artery.The polarx balloon was removed from the heart.A guide was placed inside the polarsheath to assist in finding the way back to the trans-septal puncture.It was successful.The balloon was flushed before re-introducing it in the polarsheath.An ablation of the right inferior pv was performed.It was at this time, the st elevation occurred.After a few minutes of drug delivery by the anesthetic physician, there was no improvement.The patient's heart was checked using the trans-esophageal echo.There were bubbles in the right ventricle (rv) and epicardial effusion.The physician performed pericardial aspiration.The epicardial effusion was not decreasing.The sheath perforated the right ventricle.The patient experienced tamponade.Three veins were ablated before the patient's condition became so critical that ablation was stopped.The heart surgeon decided to perform open heart surgery to close the hole in the heart.The surgery was performed in the ep lab.They closed the hole and closed the sternum afterwards.The patient went into special care.

• Brand Name: POLARSHEATH
• Manufacturer (Section D): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 302 parkway; global park, la aurora; heredia ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 14251992
• MDR Text Key: 290441490
• Report Number: 2134265-2022-04987
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• 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: 04/19/2022
• 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
• Treatment: POLARMAP; POLARX BALLOON CATHETER
• Patient Outcome(s): Life Threatening; Required Intervention