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 Problems Cardiac Tamponade (2226); Heart Block (4444)

Event Date 04/26/2023

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

It was reported that during a procedure using an intellamap orion high resolution mapping catheter (orion) the patient experienced cardiac tamponade and heart block.At the end of the procedure tamponade was observed in the left ventricle.The orion catheter had been the only catheter that had entered the left ventricle.During the procedure there was a time where there had been a "sharp movement" of the catheter while pacing during av block.No interventions were reported for the tamponade, however, the hospitalization period for the patient was extended.The patient is now reported to have recovered.The procedure had been completed with the original device and the catheter is not expected to 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 degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 16987345
• MDR Text Key: 315794362
• Report Number: 2124215-2023-25367
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 08714729841968
• UDI-Public: 08714729841968
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 05/23/2023

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: 04/06/2024
• Device Model Number: 87035
• Device Catalogue Number: 87035
• Device Lot Number: 0030289219
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/26/2023
• Initial Date FDA Received: 05/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2022
• 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
• Patient Outcome(s): Hospitalization