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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
Lot Number 0028798416
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/23/2022
Event Type  malfunction  
Event Description
It was reported that a polarsheath was used in a cryo-ablation procedure.During withdrawal / closure of a procedure when the balloon was removed a back flow was confirmed from the three-way stopcock and air was removed into a 20cc syringe.The procedure was completed without any patient complications.The deceive is expected to be returned.
 
Manufacturer Narrative
The device was returned to boston scientific for analysis.Visual inspection revealed no visual abnormalities.The sheath passed all standard manufacturing testing and was able to maintain a pressure with and without a dilator inserted.The sheath handle was disassembled and no leaks were observed.Therefore, the reported allegation could not be confirm.
 
Event Description
It was reported that a polarsheath was used in a cryo-ablation procedure.During withdrawal / closure of a procedure when the balloon was removed a back flow was confirmed from the three-way stopcock and air was removed into a 20cc syringe.The procedure was completed without any patient complications.The deceive is expected to be returned.
 
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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 
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 Key15054737
MDR Text Key296225423
Report Number2134265-2022-08004
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 08/31/2022
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 Date12/14/2022
Device Lot Number0028798416
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/05/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/23/2022
Initial Date FDA Received07/19/2022
Supplement Dates Manufacturer Received08/04/2022
Supplement Dates FDA Received08/31/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/02/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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