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 Ischemia Stroke (4418)

Event Date 11/08/2022

Event Type  Injury  

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.

Event Description

It was reported that following an ablation procedure to treat atrial flutter (af) using an intellamap orion high resolution mapping catheter and a intellanav stablepoint open-irrigated catheter the patient experienced a stroke.The procedure had been completed and no other patient complications were reported during the procedure.The nature of the stroke is unknown, and no interventions were reported to have taken place.The issue was resolved with no lasting complications.The catheter is not expected to be returned as it was disposed of after the 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: 16908323
• MDR Text Key: 314971535
• Report Number: 2124215-2023-23147
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K143481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/10/2023

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 Model Number: 87035
• Device Catalogue Number: 87035
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/10/2023
• Initial Date FDA Received: 05/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 STABLEPOINT OPEN-IRRIGATED
• Patient Outcome(s): Other
• Patient Age: 58 YR
• Patient Sex: Male