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 02/11/2023

Event Type  Injury  

Event Description

(b)(4) interrupt af clinical study, subject id: (b)(4).It was reported that after an ablation procedure to treat subventricular tachycardia using an intellamap orion high resolution mapping catheter and intellanav mifi open-irrigated catheter, the patient experienced chest pain.The procedure was performed on (b)(6)2023 the patient experienced pleuritic chest pain.The patient was given colchicine and the issue was considered resolved on (b)(6)2023.The original procedure was completed successfully, and no other complications were reported.The catheter is not expected to be returned as the complication occurred after the procedure.

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

Pm009 interrupt af clinical study, subject id: (b)(6).It was reported that after an ablation procedure to treat subventricular tachycardia using an intellamap orion high resolution mapping catheter (orion) and intellanav mifi open-irrigated catheter the patient experienced chest pain.The procedure was performed on (b)(6) 2023 and on (b)(6) 2023 the patient experienced pleuritic chest pain.They were given colchicine and the issue was considered resolved on (b)(6) 2023.The original procedure was completed successfully, and no other complications were reported.The catheter is not expected to be returned as the complication occurred after the procedure.

Manufacturer Narrative

Since the initial vigilance report was submitted for the above referenced event, boston scientific has completed its investigation, including a medical safety review.Based on the results of this review, boston scientific no longer considered the chest pain related to the use of the intella map orion mapping catheter.The orion catheter is diagnostic and as the adverse event of chest pain did not occur during the mapping/ablation procedure.It was determined the pain was related to the ablation portion of the procedure itself and not the present of the mapping catheter during said procedure.

• 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: 16994584
• MDR Text Key: 315874218
• Report Number: 2124215-2023-21360
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/29/2023

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: 03/01/2023
• Initial Date FDA Received: 05/24/2023
• Supplement Dates Manufacturer Received: 03/01/2023
• Supplement Dates FDA Received: 08/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: INTELLANAV MIFI OPEN-IRRIGATED; INTELLANAV MIFI OPEN-IRRIGATED
• Patient Outcome(s): Other
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 67 KG