MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number 87035

Device Problems Display or Visual Feedback Problem (1184); Poor Quality Image (1408)

Patient Problem Cardiac Tamponade (2226)

Event Date 02/07/2024

Event Type  Injury  

Event Description

It was reported that the patient experienced a cardiac tamponade.During an ablation procedure to treat an atrial fibrillation (afib), an intellamap orion high resolution mapping catheter was selected for use.Normal mapping was performed in the right atrium (ra), and since it was necessary to proceed to left atrium (la), a brockenbrough transseptal puncture was performed.Entered the la and the intellamap orion catheter was having a deployment detection failure, and the problem could not be resolved.Also, the potential was quite noisy.There were no particular problems with positioning reference or tracking region.While working to solve this problem, a cardiac tamponade occurred.Intracardiac echo was performed to locate the perforation.Drainage was performed immediately, and the blood pressure stabilized.Damage may have been caused during the brockenbrough or when intellamap orion high resolution mapping catheter was moved in the left superior pulmonary vein.The procedure was canceled.Catheter is expected to be returned for further analysis.

Manufacturer Narrative

The intellamap orion catheter was evaluated by boston scientific.The returned device was analyzed, passed all tests performed, and exhibited normal device characteristics.Based on the information provided, the reported event of cardiac tamponade is a known inherent risk of the intellamap orion catheter.The instructions for use state: "serious adverse events have been reported in the literature in relation to cardiac catheterization including: cardiac tamponade" there were no indications that the device was used outside the bounds of labeled/indicated use.

Event Description

It was reported that the patient experienced a cardiac tamponade.During an ablation procedure to treat an atrial fibrillation (afib), an intellamap orion high resolution mapping catheter was selected for use.Normal mapping was performed in the right atrium (ra), and since it was necessary to proceed to left atrium (la), a brockenbrough transseptal puncture was performed.Entered the la and the intellamap orion catheter was having a deployment detection failure, and the problem could not be resolved.Also, the potential was quite noisy.There were no particular problems with positioning reference or tracking region.While working to solve this problem, a cardiac tamponade occurred.Intracardiac echo was performed to locate the perforation.Drainage was performed immediately, and the blood pressure stabilized.Damage may have been caused during the brockenbrough or when intellamap orion high resolution mapping catheter was moved in the left superior pulmonary vein.The procedure was canceled.Catheter was returned for laboratory analysis.

• 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: 18816443
• MDR Text Key: 336661528
• Report Number: 2124215-2024-11731
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 08714729841968
• UDI-Public: 08714729841968
• 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,Followup
• Report Date: 04/19/2024

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
• Device Lot Number: 0032343279
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2024
• Initial Date FDA Received: 03/01/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2023
• 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): Required Intervention