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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION POLARIS X; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
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BOSTON SCIENTIFIC CORPORATION POLARIS X; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING Back to Search Results
Model Number 86080
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/04/2022
Event Type  malfunction  
Event Description
It was reported that during preparation for a procedure with a polaris x steerable diagnostic catheter, there was grease coming out of the catheter handle.The procedure was completed without any patient complications.
 
Manufacturer Narrative
The polaris x steerable diagnostic catheter was returned to boston scientific for analysis.Visual inspection noted a foreign material that was found between the handle and the thumbwheel of the catheter.During media analysis the device showed a foreign material that was found between the handle and the thumbwheel of the catheter.Based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications/instructions for use (ifu).It was confirmed this device met specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.
 
Event Description
It was reported that during preparation for a procedure with a polaris x steerable diagnostic catheter, there was grease coming out of the catheter handle.The procedure was completed without any patient complications.The polaris x steerable diagnostic catheter was returned to boston scientific for analysis.
 
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Brand Name
POLARIS X
Type of Device
CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
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 Key14242158
MDR Text Key290452944
Report Number2134265-2022-04947
Device Sequence Number1
Product Code DRF
UDI-Device Identifier08714729270171
UDI-Public08714729270171
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K003452
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 06/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/28/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/25/2023
Device Model Number86080
Device Catalogue Number86080
Device Lot Number0028451262
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/18/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/07/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/25/2021
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
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