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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 Problems High impedance (1291); Poor Quality Image (1408); Activation, Positioning or Separation Problem (2906); Difficult to Open or Remove Packaging Material (2922)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/22/2021
Event Type  malfunction  
Event Description
It was reported an intellamap orion high resolution mapping catheter was used in a pulmonary vein isolation (pvi) procedure to treat atrial fibrillation.During preparation, while opening the package, it was noted that the insertion tool was loose at the bottom of the packaging making the physician unable to remove the insertion tool while maintaining sterility.The orion was connected and conditioned successfully and inserted without using a insertion tool.The orion was then advanced into an non-boston scientific sheath via a smaller diameter split away sheath.Once into the chamber of interest, the system failed to detect the orion's deployment.The rhyhmia mapping specialist viewed the 8x8 graph and all electrodes on the orion were "noisy and high impedance / red." it was thought that the mini electrodes may have been damaged by the hemostasis value due to the lack of an insertion tool.The orion was replaced and the issue resolved with no patient complications reported.
 
Event Description
It was reported an intellamap orion high resolution mapping catheter was used in a pulmonary vein isolation (pvi) procedure to treat atrial fibrillation.During preparation, while opening the package, it was noted that the insertion tool was loose at the bottom of the packaging making the physician unable to remove the insertion tool while maintaining sterility.The orion was connected and conditioned successfully and inserted without using a insertion tool.The orion was then advanced into an non-boston scientific sheath via a smaller diameter split away sheath.Once into the chamber of interest, the system failed to detect the orion's deployment.The rhyhmia mapping specialist viewed the 8x8 graph and all electrodes on the orion were "noisy and high impedance / red." it was thought that the mini electrodes may have been damaged by the hemostasis value due to the lack of an insertion tool.The orion was replaced and the issue resolved with no patient complications reported.
 
Manufacturer Narrative
Visual inspection of the device showed no visual issues detected.The packaging was not returned for inspection.During functional testing the deployment issue was confirmed, no deployment was noted due to a magnetic registration problem.There is no evidence this device was used in a manner inconsistent with the labeled indications.It was confirmed this device met specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.
 
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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 Key12831038
MDR Text Key280938722
Report Number2134265-2021-14462
Device Sequence Number1
Product Code DRF
UDI-Device Identifier08714729841968
UDI-Public08714729841968
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K143481
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/23/2022
Device Model Number87035
Device Catalogue Number87035
Device Lot Number0027545534
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/08/2021
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/22/2021
Initial Date FDA Received11/17/2021
Supplement Dates Manufacturer Received12/08/2021
Supplement Dates FDA Received01/07/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/23/2021
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
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