MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number 87035

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Nausea (1970); Dizziness (2194)

Event Date 02/10/2023

Event Type  Injury  

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 Description

Subject id: (b)(4).An intellamap orion high resolution mapping catheter was selected for use.After the procedure the patient developed nausea, vomiting and dizziness.Labs revealed acute-on-chronic hyponatremia.One day after the procedure the patient was feeling symptomatic.She stated these symptoms were similar to when she had low sodium in the past.Nephrology was consulted and transferred the patient to intensive care unit for hypertonic saline infusion.Strict postoperative fluid restriction was observed, and patient was started on 3% saline.She had q6h labs checked which showed progressive improvement in sodium trend.Hypertonic saline infusion was stopped two days later.Patient was clinically stable throughout this period.The patient symptoms of nausea/vomiting and dizziness resolved by evening of day 1 and has since remained relatively asymptomatic.

• Brand Name: INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER
• 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: 16558981
• MDR Text Key: 311470925
• Report Number: 2124215-2023-12196
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 08714729841968
• UDI-Public: 08714729841968
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/03/2024
• Device Model Number: 87035
• Device Catalogue Number: 87035
• Device Lot Number: 0030267592
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2023
• Initial Date FDA Received: 03/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 67 KG