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

Model Number	86080
Medical Device Problem Codes	Material Perforation (2205); Defective Device (2588)
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 a procedure a polaris x catheter was selected for use.There were scratches on the catheter shaft where the blue plastic was pulling away.The scratches were observed upon opening the catheter out of the box.The procedure was completed with a new device and without any patient complications.
Additional Manufacturer Narrative
The device was returned to boston scientific for analysis.Upon analysis visual inspection revealed residues of adhesive were found around the shaft.Therefore, the reported complaint is confirmed.Correction: e1.

• 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: 15429571
• Report Number: 2124215-2022-36180
• Device Sequence Number: 4622328
• Product Code: DRF
• UDI-Device Identifier: 08714729270188
• UDI-Public: 08714729270188
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2022

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: 05/01/2024
• Device Model Number: 86080
• Device Catalogue Number: 86080
• Device Lot Number: 0029323483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2022
• Type of Report(Section G): Initial
• 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: 12/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown