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

Model Number	M0047003D0
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
During an electrophysiology ablation a polaris x was selected for use.The patient had a different cardiac anatomy, so access to the coronary sinus was more difficult than usual.This made it more difficult for the doctor to access it.In order to do this, the physician had to force the catheter a little more than usual and this ended up damaging the polaris x catheter, even fracturing some of the electrodes.The procedure was completed.No patient complications were reported.The device is expected to return.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory.Visual inspection revealed the device was visually inspected and revealed multiple kinks and twists in the last 10cm of the distal end that correspond to the grey area of the catheter shaft.The allegation of catheter damage from the field was confirmed.The most likely cause was determined to be an adverse event related to the procedure.
Event or Problem Description
During an electrophysiology ablation a polaris x was selected for use.The patient had a different cardiac anatomy, so access to the coronary sinus was more difficult than usual.This made it more difficult for the doctor to access it.In order to do this, the physician had to force the catheter a little more than usual and this ended up damaging the polaris x catheter, even fracturing some of the electrodes.The procedure was completed.No patient complications were reported.The device is expected to return.
Event or Problem Description
During an electrophysiology ablation a polaris x was selected for use.The patient had a different cardiac anatomy, so access to the coronary sinus was more difficult than usual.This made it more difficult for the doctor to access it.In order to do this, the physician had to force the catheter a little more than usual and this ended up damaging the polaris x catheter, even fracturing some of the electrodes.The procedure was completed.No patient complications were reported.The device is expected to return.
Additional Manufacturer Narrative
This report is being filed as a correction in response to an fda request for the complete unique identifier (udi) # and to correct discrepancies with product information in the gudid database.Upon receipt at our post market quality assurance laboratory.Visual inspection revealed the device was visually inspected and revealed multiple kinks and twists in the last 10cm of the distal end that correspond to the grey area of the catheter shaft.The allegation of catheter damage from the field was confirmed.The most likely cause was determined to be an adverse event related to the procedure.

• 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: 17967986
• Report Number: 2124215-2023-57239
• Device Sequence Number: 7623800
• Product Code: DRF
• UDI-Device Identifier: 08714729270164
• UDI-Public: (01)08714729270164(17)250528(10)31711844
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/06/2024

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: 05/28/2025
• Device Model Number: M0047003D0
• Device Catalogue Number: M0047003D0
• Device Lot Number: 0031711844
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2023
• Supplement Date Received by Manufacturer: 02/14/2024; 07/09/2024
• Initial Report FDA Received Date: 10/19/2023
• Supplement Report FDA Received Date: 02/29/2024; 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown