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

Model Number	86080
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During preparation for a procedure as two polaris x catheters were taken out of the box, there were scratches on the catheter shafts where the blue plastic was pulling away.The procedure was completed with a new device and without any patient complications.The catheters have been returned for analysis.
Event or Problem Description
During preparation for a procedure as two polaris x catheters were taken out of the box, there were scratches on the catheter shafts where the blue plastic was pulling away.The procedure was completed with a new device and without any patient complications.
Additional Manufacturer Narrative
The catheter was returned to boston scientific for analysis.Upon analysis visual inspection revealed foreign material was found around the shaft.The foreign material was analyzed, and the spectrum of the foreign material presented an adhesive like material, therefore, confirming the reported complaint.Functional inspection revealed no abnormal resistance was felt when actuating the steering mechanism.

• 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: 15429557
• Report Number: 2124215-2022-36179
• Device Sequence Number: 4621827
• Product Code: DRF
• UDI-Device Identifier: 08714729270188
• UDI-Public: 08714729270188
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 12/06/2022

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: 03/30/2024
• Device Model Number: 86080
• Device Catalogue Number: 86080
• Device Lot Number: 0029146916
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/18/2022
• Supplement Date Received by Manufacturer: 11/08/2022
• Initial Report FDA Received Date: 09/15/2022
• Supplement Report FDA Received Date: 12/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown