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 Rupture (2208); Cardiac Tamponade (2226)

Event Date 09/28/2021

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

During a rhythmia mapping procedure to treat ischemic ventricular tachycardia (vt) an intellamap orion high resolution mapping catheter was selected for use.A left ventricle (lv) vt map was created from both accesses.When the orion exchanged from retro-aortic access to transeptal access.The physician tried to access lv again from transeptal access then realized in one moment that the physician wasn't sure where the physician was anatomically because in one moment it seems the orion was out of the cardiac silhouette.A few seconds later, the physician realized that patient had a pericardial effusion and they started their protocol with pericardiocentesis kit trying to remove all the blood form the pericardium.The catheter was in the left atrium when pericardial effusion and cardiac tamponade were discovered in the few seconds after they saw orion out of the cardiac silhouette.After removing 1,5 liters of fluid via pericardiocentesis , they decided to call a cardiac surgeon to stitch in the mitral annulus.Further treatment of ischemic ventricular tachycardia was cancelled.The patient is expected to fully recover.

• 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: 12594433
• MDR Text Key: 275435640
• Report Number: 2134265-2021-12578
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K143481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/07/2021

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 Model Number: 87035
• Device Catalogue Number: 87035
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2021
• Initial Date FDA Received: 10/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention