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

Model Number	86080
Medical Device Problem Codes	Defective Device (2588); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/08/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.A polaris x was selected for an ablation procedure; however, it was noted that the catheter shaft broke.The procedure was completed with another catheter.No patient complications reported.
Additional Manufacturer Narrative
Analysis of returned product revealed corrosion within the handle of the device that have caused a material degradation that leads to the breakage of the solder ball from the pull wire, making impossible the curve actuation.Functional inspection failed since there was no movement of the tip during thumb-slide actuation.Dimensional inspection failed since the curve was found out of specification due to there was no movement of the tip during thumb-slide actuation.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
Event or Problem Description
It was reported that shaft break occurred.A polaris x was selected for an ablation procedure; however, it was noted that the catheter shaft broke.The procedure was completed with another catheter.No patient complications reported.

• Brand Name: POLARIS X
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 8586466
• Report Number: 2134265-2019-04942
• Device Sequence Number: 16596647
• Product Code: DRF
• UDI-Device Identifier: 08714729270164
• UDI-Public: 08714729270164
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K003452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2019

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: 03/21/2020
• Device Model Number: 86080
• Device Catalogue Number: 86080
• Device Lot Number: 0022719789
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2019
• Initial Date Received by Manufacturer: 04/08/2019
• Supplement Date Received by Manufacturer: 05/21/2019
• Initial Report FDA Received Date: 05/07/2019
• Supplement Report FDA Received Date: 06/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 43 YR