MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAMIC XT; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number 86706

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

Patient Problems Cardiomyopathy (1764); Chest Pain (1776); Dyspnea (1816); Tachycardia (2095)

Event Date 09/29/2022

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

Interrupt af clinical study (b)(4): subject id: (b)(4).An index ablation procedure involving an intellamap orion catheter, dynamic xt electrode catheter, and intellanav mifi oi catheter was successfully completed on (b)(6) 2022.It was reported that on (b)(6) 2022, the patient was admitted to the emergency room after waking up with complaints of tachycardia, pressure on the chest and dyspnea.An electrocardiogram (ecg) in the emergency unit showed atrial tachycardia.The suspected cause is atrial cardiomyopathy.The patient's oral medication was changed or adjusted to dronedarone, and a diagnostic ep study was performed.This issue was resolved (b)(6) 2022.

• Brand Name: DYNAMIC XT
• 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: 15619044
• MDR Text Key: 301896611
• Report Number: 2124215-2022-41764
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K921872
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/17/2022

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 Model Number: 86706
• Device Catalogue Number: 86706
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2022
• Initial Date FDA Received: 10/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER.; INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETER.
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 76 KG