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

Model Number 86080

Device Problems Material Perforation (2205); Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/18/2022

Event Type  malfunction  

Event 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 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.

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
• Type of Device: 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
• MDR Text Key: 304695013
• Report Number: 2124215-2022-36180
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 08714729270188
• UDI-Public: 08714729270188
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K003452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 08/18/2022
• Initial Date FDA Received: 09/15/2022
• Supplement Dates Manufacturer Received: 11/08/2022
• Supplement Dates FDA Received: 12/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/02/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1