Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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
Model Number M004CRBS3050
Device Problems Leak/Splash (1354); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Non specific EKG/ECG Changes (1817); ST Segment Elevation (2059)
Event Date 12/01/2020
Event Type  Injury  
Event Description
It was reported that during a pulmonary vein isolation (pvi) cryoablation procedure to treat paroxysmal atrial fibrillation, the polarsheath was prepared and used following the new sheath management guidelines, continuously flushed with a pressure bag.The dilator was wiped with saline prior to introduction into the valve.The polarsheath dilator and polarx balloon were placed across the valve.They ablated the left veins without issues.When they ablated the right superior pulmonary vein (rspv), they noted an st segment elevation and stopped the ablation.They tried aspiration from the sheath while the polarx balloon was in left atrium (la).They were able to aspirate a lot of air.They then took out the polarx and aspirated it again - no air was aspirated that time.They waited for the st segment elevation to resolve and then again introduced the balloon inside the polarsheath and aspirated with balloon in la.Again, they were able to aspirate air.It was decided to replace the polarsheath.After the polarsheath was replaced, the procedure was completed successfully.The st segment elevation resolved prior to any additional ablations.The polarx was in place when the leak occurred.They only saw the st segment elevation, without fluid coming from the sheath's valve.After taking out the catheter, they could aspirate a lot of air.No fluid was seen out of the sheath.The air was going inside the hemostatic valve.The patient was fine after the procedure.The devices are expected to be returned for analysis.
 
Event Description
It was reported that during a pulmonary vein isolation (pvi) cryoablation procedure to treat paroxysmal atrial fibrillation, the polarsheath was prepared and used following the new sheath management guidelines, continuously flushed with a pressure bag.The dilator was wiped with saline prior to introduction into the valve.The polarsheath dilator and polarx balloon were placed across the valve.They ablated the left veins without issues.When they ablated the right superior pulmonary vein (rspv), they noted an st segment elevation and stopped the ablation.They tried aspiration from the sheath while the polarx balloon was in left atrium (la).They were able to aspirate a lot of air.They then took out the polarx and aspirated it again - no air was aspirated that time.They waited for the st segment elevation to resolve and then again introduced the balloon inside the polarsheath and aspirated with balloon in la.Again, they were able to aspirate air.It was decided to replace the polarsheath.After the polarsheath was replaced, the procedure was completed successfully.The st segment elevation resolved prior to any additional ablations.The polarx was in place when the leak occurred.They only saw the st segment elevation, without fluid coming from the sheath's valve.After taking out the catheter, they could aspirate a lot of air.No fluid was seen out of the sheath.The air was going inside the hemostatic valve.The patient was fine after the procedure.The devices were returned for analysis.
 
Manufacturer Narrative
The device was returned to boston scientific for analysis.The polarsheath device valve outer surfaces are relatively intact, and did not have significant tears.The flushing line was kinked where the flushing line exits the handle.When allowing the flushing line to kink at the location identified, the device was difficult to irrigate and aspirate; a vacuum developed while pulling on the syringe.Further tests were performed with the flushing line held in a straightened position.The device passed air positive pressure, fluid leak, and air ingress testing with an empty valve.However, the polarsheath did not pass various leak and air ingress testing while a polarx catheter or dilator was inserted, removed, or when tipped at slight angles (relative to the sheath).There is no evidence to suggest that this device was used in a manner inconsistent with the labeled indications.It was confirmed this device met specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
POLARSHEATH
Manufacturer (Section D)
BOSTON SCIENTIFIC DE COSTA RICA S.R.L.
302 parkway
global park, la aurora
heredia
CS 
MDR Report Key11012756
MDR Text Key221726914
Report Number2134265-2020-17811
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 03/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/19/2021
Device Model NumberM004CRBS3050
Device Lot Number0025977551
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/14/2020
Date Manufacturer Received03/15/2021
Patient Sequence Number1
Treatment
POLARX; POLARX
Patient Outcome(s) Other;
-
-