MAUDE Adverse Event Report: BOSTON SCIENTIFIC DE COSTA RICA S.R.L. POLARMAP; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	M004CRBS7210
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that during the preparation of a cryoablation procedure to treat an atrial fibrillation (af), a polarmap catheter was selected for use.Device became unsterile and it was decided to replace it rather than proceed.Procedure was able to be completed successfully without any patient complications.Device is not expected to be returned as it was disposed.
Event or Problem Description
It was reported that during the preparation of a cryoablation procedure to treat an atrial fibrillation (af), a polarmap catheter was selected for use.Device became unsterile and it was decided to replace it rather than proceed.Procedure was able to be completed successfully without any patient complications.Device is not expected to be returned as it was disposed.It was further reported that the catheter was looped on the patient field.It became unsterile when unwrapped and it hit the scrub nurse in the head.
Additional Manufacturer Narrative
Additional information added to b5: describe event or problem it was indicated that the device will not be returned for evaluation.It was further reported via additional information that the device became unsterile while being handled by the nurse during preparation.If there is any further relevant information obtained, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that during the preparation of a cryoablation procedure to treat an atrial fibrillation (af), a polarmap catheter was selected for use.Device became unsterile and it was decided to replace it rather than proceed.Procedure was able to be completed successfully without any patient complications.Device is not expected to be returned as it was disposed.It was further reported that the catheter was looped on the patient field.It became unsterile when unwrapped and it hit the scrub nurse in the head.
Additional Manufacturer Narrative
Udi related data quality updates only.This report is being filed as a correction in response to an fda request for the complete the unique identifier (udi) #.It was indicated that the device will not be returned for evaluation.It was further reported via additional information that the device became unsterile while being handled by the nurse during preparation.If there is any further relevant information obtained, a supplemental medwatch will be filed.

• Brand Name: POLARMAP
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 302 parkway; global park, la aurora; heredia ; CS
• 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: 18393473
• Report Number: 2124215-2023-72193
• Device Sequence Number: 2659074
• Product Code: DRF
• UDI-Device Identifier: 00191506039769
• UDI-Public: (01)00191506039769(17)20250713(10)0031998812
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K223824
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/25/2024

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: 07/13/2025
• Device Model Number: M004CRBS7210
• Device Lot Number: 0031998812
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2023
• Supplement Date Received by Manufacturer: 12/27/2023; 07/09/2024
• Initial Report FDA Received Date: 12/26/2023
• Supplement Report FDA Received Date: 01/12/2024; 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown