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

Model Number 86736

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

Patient Problem Ischemia Stroke (4418)

Event Date 01/21/2021

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis and the complaint as reported could not be confirmed.Based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.

Event Description

It was reported that a rhythmia mapping and ablation procedure was completed with a intellamap orion high resolution mapping, intellanav stablepoint open-irrigated, and dynamic xt catheters.However post procedure it was noted that the patient experienced a stroke.

• 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: 11878253
• MDR Text Key: 252707919
• Report Number: 2134265-2021-06769
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 08714729879909
• UDI-Public: 08714729879909
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K921872
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/25/2021

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: 11/04/2023
• Device Model Number: 86736
• Device Catalogue Number: 86736
• Device Lot Number: 0026304868
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/12/2021
• Initial Date FDA Received: 05/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other