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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
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BOSTON SCIENTIFIC DE COSTA RICA S.R.L. POLARSHEATH; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING Back to Search Results
Model Number M004CRBSUSC3050
Device Problem Leak/Splash (1354)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/29/2020
Event Type  malfunction  
Manufacturer Narrative
The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
 
Event Description
During a cryoablation procedure to treat atrial fibrillation a polarsheath was selected for use.It was reported that air was aspirated into the sheath and hemostatic valve during irrigation prior to the start of the procedure.Aspiration was slowed by placing a finger over the hemostatic valve.The sheath was never inserted into the patient so the procedure was resumed after exchanging the sheath.No fluid lead was observed.The procedure was completed with no patient complications.
 
Manufacturer Narrative
The device was returned to boston scientific for analysis.With all the available information, boston scientific concludes the reported failure of sheath leak was not confirmed through investigational analysis.Visual inspection revealed that the valve had a tear in the seal connected to the outer slit.The device was received with a dilator inserted into the sheath.No functional testing can be performed due to inaccurate results from having the dilator inserted into the sheath.The sterilization process influences the amount of silicon oil inside the hemostatic valve, causing inconsistencies on the physical device.When the dilator is pulled out of the sheath, the valve would be too dry for a smooth transition and causing larger than standard tear, leading to inaccurate results per testing methods.Regardless, a leak was performed by gently pressurizing the device with 6 psi at the flushing line luer fitting while plugging the distal tip of the catheter.The valve body was then submerged in a beaker of water.A steady stream of bubbles appeared at the valve region at the tear(s) and valve slits.There is no evidence this device was used in a manner inconsistent with the labeled indications.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
 
Event Description
During a cryoablation procedure to treat atrial fibrillation a polarsheath was selected for use.It was reported that air was aspirated into the sheath and hemostatic valve during irrigation prior to the start of the procedure.Aspiration was slowed by placing a finger over the hemostatic valve.The sheath was never inserted into the patient so the procedure was resumed after exchanging the sheath.No fluid lead was observed.The procedure was completed with no patient complications.
 
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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 
MDR Report Key10900287
MDR Text Key219328328
Report Number2134265-2020-16396
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,health
Type of Report Initial,Followup
Report Date 02/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/25/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/22/2021
Device Model NumberM004CRBSUSC3050
Device Lot Number0025996540
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/09/2020
Date Manufacturer Received02/02/2021
Patient Sequence Number1
Patient Age72 YR
Patient Weight90
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