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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
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BOSTON SCIENTIFIC CORPORATION INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING Back to Search Results
Model Number 87035
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Air Embolism (1697); Stroke/CVA (1770); Non specific EKG/ECG Changes (1817); Ventricular Fibrillation (2130); Obstruction/Occlusion (2422); Convulsion/Seizure (4406)
Event Date 06/03/2022
Event Type  Injury  
Event Description
During a myocardial ablation to treat atrial fibrillation in the left atrium a intellamap orion high resolution mapping catheter was selected for use.The case started by connecting a pressure bag containing saline solution to the catheter, but the handle part was found to be wet.Therefore, the connection with the catheter was checked, and the reflux was resumed, then ecg st elevation occurred during the case, and tamponade was suspected.There was a possibility of air embolism due to a seizure and ventricular fibrillation.When the system was checked, the catheter pressure bag saline solution was empty.The saline solution in the pressure bag did not bleed, so it is suspected that the air in the saline solution was mixed.The procedure was reschedule/ cancelled.It was further reported that no cardiac tamponade occurred.Furthermore, there was no malfunction against the catheter.The patient is receiving treatment for cerebral infarction.The patient is recovering and has moved to the general ward.
 
Event Description
During a myocardial ablation to treat atrial fibrillation in the left atrium a intellamap orion high resolution mapping catheter was selected for use.The case started by connecting a pressure bag containing saline solution to the catheter, but the handle part was found to be wet.Therefore, the connection with the catheter was checked, and the reflux was resumed, then ecg st elevation occurred during the case, and tamponade was suspected.There was a possibility of air embolism due to a seizure and ventricular fibrillation.When the system was checked, the catheter pressure bag saline solution was empty.The saline solution in the pressure bag did not bleed, so it is suspected that the air in the saline solution was mixed.The procedure was reschedule/ cancelled.It was further reported that no cardiac tamponade occurred.Furthermore, there was no malfunction against the catheter.The patient is receiving treatment for cerebral infarction.The patient is recovering and has moved to the general ward.
 
Manufacturer Narrative
The device was received at boston scientific for analysis.Visual inspection revealed no visual abnormalities.Functional examination revealed the catheter was able to map, detect, and deploy.A leak test performed did not identify a leak during testing.The reported event was not confirmed.
 
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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 Key14879262
MDR Text Key295116071
Report Number2134265-2022-07563
Device Sequence Number1
Product Code DRF
UDI-Device Identifier08714729841968
UDI-Public08714729841968
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K143481
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 08/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/30/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date02/09/2023
Device Model Number87035
Device Catalogue Number87035
Device Lot Number0027812698
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/14/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/15/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/10/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Required Intervention;
Patient Age56 YR
Patient SexFemale
Patient Weight63 KG
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