• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC DE COSTA RICA S.R.L. POLARSHEATH Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePOLARSHEATH
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 Key14251992
MDR Text Key290441490
Report Number2134265-2022-04987
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
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 Received04/29/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/19/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/29/2022 Patient Sequence Number: 1
Treatment
POLARMAP; POLARX BALLOON CATHETER
-
-