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 Problem Chest Pain (1776)

Event Date 02/26/2019

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

Clinical patient id (b)(6).An atrial fib ablation a intellamap orion high resolution mapping catheter was selected for use.Pre discharge (no more than 2 days after the procedure) the patient experienced chest pain due to pleuropericardial inflammation.The pain was resolved by colchicine during day 7.Clinical patient id (b)(6).During a procedure to treat atrial fibrillation a intellamap orion high resolution mapping catheter was used.Prior to discharge no more than 2 days after the procedure, the patient experienced chest pain due to pleuropericardial inflammation.The patient was prescribed colchicine and the pain was resolved by day 7.There was indication if product will be returned.

• 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 ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 17167075
• MDR Text Key: 317532600
• Report Number: 2124215-2023-31130
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/20/2023

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: 09/17/2019
• Device Model Number: 87035
• Device Catalogue Number: 87035
• Device Lot Number: 0022781246
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/22/2023
• Initial Date FDA Received: 06/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: DYNAMIC XT; INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETER
• Patient Outcome(s): Other