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

Model Number	86080
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: under 18 years old.
Event or Problem Description
It was reported that a wire on the catheter was exposed.During an ablation procedure for right atrial flutter, the physician observed that there was an exposed wire behind the second electrode of the polaris x catheter.It appeared that the covering had disconnected.The catheter had been in the patient's right atrium.It was exchanged for another catheter of the same model and the procedure was successfully completed.There were no patient complications.
Additional Manufacturer Narrative
A2: age at time of event: under 18 years old.Visual inspection of the catheter showed there was foreign matter present in the distal tip, over the tip electrode and ring #1.The foreign matter was removed, and the distal section of the catheter appeared intact.X-ray examination revealed no anomalies; all of the internal wires and the steering mechanism were correctly in place.The catheter condition and the material of the catheter were intact and in good condition and no issues were detected after removal of the foreign matter; therefore, it is possible that the foreign matter found in the distal tip of the device was tissue from the anatomy location of the patient that remained in the catheter as a result of the procedure.The reported complaint was not confirmed through device analysis.The investigation conclusion is: no problem detected.A review of the manufacturing records was performed and no issues that could have contributed to this event were found.Furthermore, the review of the manufacturing records did not identify any failure of the product to meet its material, assembly, or performance specifications.
Event or Problem Description
It was reported that a wire on the catheter was exposed.During an ablation procedure for right atrial flutter, the physician observed that there was an exposed wire behind the second electrode of the polaris x catheter.It appeared that the covering had disconnected.The catheter had been in the patient's right atrium.It was exchanged for another catheter of the same model and the procedure was successfully completed.There were no patient complications.

• 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: 9141676
• Report Number: 2134265-2019-11848
• Device Sequence Number: 1825802
• Product Code: DRF
• UDI-Device Identifier: 08714729270164
• UDI-Public: 08714729270164
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K003452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2019

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 Model Number: 86080
• Device Catalogue Number: 86080
• Device Lot Number: 0023682090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2019
• Initial Date Received by Manufacturer: 09/04/2019
• Supplement Date Received by Manufacturer: 10/03/2019
• Initial Report FDA Received Date: 10/01/2019
• Supplement Report FDA Received Date: 10/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1