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; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
  • 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; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING Back to Search Results
Lot Number 0028751790
Device Problems Leak/Splash (1354); Device Contamination with Body Fluid (2317)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/27/2022
Event Type  malfunction  
Event Description
It was reported that during a cryo ablation procedure to treat atrial fibrillation using a polarsheath blood was leaking from the side port.Ablations were completed on the left superior pulmonary vein, then the left inferior pulmonary vein, next the right superior pulmonary vein, and finally during ablation of the right inferior pulmonary vein blood was noticed to be leaking from the side port of the sheath.As the issue was noticed during the final ablation, the procedure was considered completed.There were no patient complications.The sheath has been received for analysis.
 
Event Description
It was reported that during a cryo ablation procedure to treat atrial fibrillation using a polarsheath blood was leaking from the side port.Ablations were completed on the left superior pulmonary vein, then the left inferior pulmonary vein, next the right superior pulmonary vein, and finally during ablation of the right inferior pulmonary vein blood was noticed to be leaking from the side port of the sheath.As the issue was noticed during the final ablation, the procedure was considered completed.There were no patient complications.The sheath has been received for analysis.
 
Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, the sheath was functionally tested by replicating asperation as it would happen in the field.The sheath failed asperation testing as air was visible in the flush line each time the syringe was drawn back.Next, they tested the ability of the sheath's valve to maintain pressure, and the device failed to maintain the minimum acceptable internal pressure.They then identified the location of the leaks by flushing the lure while the distal tip was plug.The leak was identified as coming from the hemostatic valve, as fluid came from the valve during this flush testing.The allegation in the complaint was confirmed as testing identified a leak in the hemostatic valve.The cause was determined to be component failure due to the failure of the valve.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
POLARSHEATH
Type of Device
CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
Manufacturer (Section D)
BOSTON SCIENTIFIC DE COSTA RICA S.R.L.
302 parkway
global park, la aurora
heredia
CS 
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
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 Key15267130
MDR Text Key302682820
Report Number2134265-2022-08636
Device Sequence Number1
Product Code DRF
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 10/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/07/2022
Device Lot Number0028751790
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/10/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/27/2022
Initial Date FDA Received08/22/2022
Supplement Dates Manufacturer Received09/07/2022
Supplement Dates FDA Received10/04/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/26/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-