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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 Data Problem (3196)
Patient Problem Cardiac Tamponade (2226)
Event Date 02/01/2021
Event Type  Injury  
Event Description
It was reported that during an ablation procedure to treat ventricular tachycardia with an intellamap orion high resolution mapping catheter and a non-boston scientific sheath, the catheter was blinking only during mapping of the right ventricular outflow tract (rvot), and it was not displayed.The intellanav mifi open-irrigated (oi) was able to be displayed.No error message displayed.Each power was rebooted, but the issue was not resolved, and the procedure was continued as it was.Prior to abating, after about 30 seconds of mapping, a cardiac tamponade was noted near the patient's rvot.A pericardial drainage was performed and the procedure was completed with stable blood pressure.The patient had no further issues.No resistance was felt during manipulating the catheter.It was unknown what caused the cardiac tamponade, but it was reported that it was a possibility that the sheath was pressed to the wall of the heart chamber too hard when it was advanced to rvot.There were no visible issues or damage with the intellamap orion high resolution mapping catheter.No electrical interference was seen on the orion.The device has been received and is pending analysis.
 
Manufacturer Narrative
The device was returned to boston scientific for analysis.Visual inspection showed no gross abnormalities.Magnetic sensor resistance test and a magnetic sensor inductance test were performed.Both pairs were in range of specification according with procedure.Hdx testing was performed.After device was unexpired, the orion unit passed all tests.Deployment showed on the workstation screen and the device had 100% mapping capabilities.Lcr testing was performed and passed.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
 
Event Description
It was reported that during an ablation procedure to treat ventricular tachycardia with an intellamap orion high resolution mapping catheter and a non-boston scientific sheath, the catheter was blinking only during mapping of the right ventricular outflow tract (rvot), and it was not displayed.The intellanav mifi open-irrigated (oi) was able to be displayed.No error message displayed.Each power was rebooted, but the issue was not resolved, and the procedure was continued as it was.Prior to abating, after about 30 seconds of mapping, a cardiac tamponade was noted near the patient's rvot.A pericardial drainage was performed and the procedure was completed with stable blood pressure.The patient had no further issues.No resistance was felt during manipulating the catheter.It was unknown what caused the cardiac tamponade, but it was reported that it was a possibility that the sheath was pressed to the wall of the heart chamber too hard when it was advanced to rvot.There were no visible issues or damage with the intellamap orion high resolution mapping catheter.No electrical interference was seen on the orion.The device has been received and is pending analysis.
 
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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
MDR Report Key11372234
MDR Text Key233269981
Report Number2134265-2021-02283
Device Sequence Number1
Product Code DRF
UDI-Device Identifier08714729841968
UDI-Public08714729841968
Combination Product (y/n)N
PMA/PMN Number
K143481
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 04/05/2021
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 Expiration Date01/08/2022
Device Model Number87035
Device Catalogue Number87035
Device Lot Number0025694722
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/19/2021
Initial Date Manufacturer Received 02/01/2021
Initial Date FDA Received02/24/2021
Supplement Dates Manufacturer Received03/15/2021
Supplement Dates FDA Received04/05/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
INTELLANAV MIFI OPEN-IRRIGATED (OI) CATHETER; INTELLANAV MIFI OPEN-IRRIGATED (OI) CATHETER; SWARTS SHEATH; SWARTS SHEATH; INTELLANAV MIFI OPEN-IRRIGATED (OI) CATHETER; SWARTS SHEATH
Patient Outcome(s) Required Intervention;
Patient Age74 YR
Patient Weight71
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