MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION POLARIS X; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	86080
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during preparation for an ablation procedure with a polaris x steerable diagnostic catheter, there was grease in the catheter handle.The procedure was completed without any patient complications.The device will be returned for laboratory analysis.
Additional 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.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 or Problem Description
It was reported that during preparation for an ablation procedure with a polaris x steerable diagnostic catheter, there was grease in the catheter handle.The procedure was completed without any patient complications.

• Brand Name: POLARIS X
• Common Device Name: 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 Key: 14242163
• Report Number: 2134265-2022-04944
• Device Sequence Number: 4159368
• Product Code: DRF
• UDI-Device Identifier: 08714729270171
• UDI-Public: 08714729270171
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K003452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/29/2023
• Device Model Number: 86080
• Device Catalogue Number: 86080
• Device Lot Number: 0028463213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2022
• Supplement Date Received by Manufacturer: 05/07/2022
• Initial Report FDA Received Date: 04/28/2022
• Supplement Report FDA Received Date: 06/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown