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

Model Number M004RC64S0

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

Patient Problems Headache (1880); Nausea (1970); Vomiting (2144); Respiratory Insufficiency (4462)

Event Date 12/06/2023

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

It was reported that after an ablation procedure to treat atrial fibrillation using an intellamap orion high resolution mapping catheter, and prior to discharge, the patient experienced pulmonary insufficiency with low oxygen saturation, nausea, vomiting, and severe headache.The patient was administered oxygen (o2) for the desaturation, and a chest x-ray and laboratory blood tests were performed for diagnostics.The patient was hospitalized for observation over the course of two days, after which the patient recovered from the complications and was discharged.The device is not expected to be returned for analysis.

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.If there is any further relevant information obtained, a supplemental medwatch will be filed.

Event Description

It was reported that after an ablation procedure to treat atrial fibrillation using an intellamap orion high resolution mapping catheter, and prior to discharge, the patient experienced pulmonary insufficiency with low oxygen saturation, nausea, vomiting, and severe headache.The patient was administered oxygen (o2) for the desaturation, and a chest x-ray and laboratory blood tests were performed for diagnostics.The patient was hospitalized for observation over the course of two days, after which the patient recovered from the complications and was discharged.The device is not expected to be returned for analysis.

• 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: 18380366
• MDR Text Key: 331177319
• Report Number: 2124215-2023-72237
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 08714729841968
• UDI-Public: (01)08714729841968(17)20240613(10)0030702243
• 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: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/25/2024

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: 06/13/2024
• Device Model Number: M004RC64S0
• Device Catalogue Number: 87035
• Device Lot Number: 0030702243
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2023
• Initial Date FDA Received: 12/21/2023
• Supplement Dates Manufacturer Received: 07/09/2024
• Supplement Dates FDA Received: 07/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: INTELLANAV MIFI OPEN-IRRIGATED; INTELLANAV MIFI OPEN-IRRIGATED
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 92 KG