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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 Difficult to Remove (1528); Activation, Positioning or Separation Problem (2906)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/19/2019
Event Type  malfunction  
Manufacturer Narrative
The device has not been received for analysis; therefore, a failure analysis of the complaint device could not be completed.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
 
Event Description
It was reported that the catheter was not able to move the catheter and unable to be un-deployed.During a redo atrial fibrillation procedure when the intellamap orion was in the left superior pulmonary vein (lspv) a spline was trapped and the operator was not able to move the catheter.The physician was unable to un-deploy the splines, after the spline got bent to the inside of the basket shape.The physician advance the sheath in order to retract the catheter.They checked outside the body and it seems ok.A new intellamap orion was used and the mapping was successfully completed.There were no patient complications reported.
 
Event Description
It was reported that the catheter was not able to move the catheter and unable to be un-deployed.During a redo atrial fibrillation procedure when the intellamap orion was in the left superior pulmonary vein (lspv) a spline was trapped and the operator was not able to move the catheter.The physician was unable to un-deploy the splines, after the spline got bent to the inside of the basket shape.The physician advance the sheath in order to retract the catheter.They checked outside the body and it seems ok.A new intellamap orion was used and the mapping was successfully completed.There were no patient complications reported.
 
Manufacturer Narrative
Visual inspection revealed no defects detected on the device.Functional testing revealed no opens or shorts.Hdx testing revealed that deployment can be seen on the work station screen without an issue and mapping capability was normal.The lcr testing revealed the boundaries were within specifications and matched the electrical test results.Diameter measurements were taken on different locations of the main shaft (tip, distal collar, 2 cm, 55 cm).The values fall into manufacturing standards, which passed the test.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
 
Event Description
It was reported that the catheter was not able to move the catheter and unable to be un-deployed.During a redo atrial fibrillation procedure when the intellamap orion was in the left superior pulmonary vein (lspv) a spline was trapped and the operator was not able to move the catheter.The physician was unable to un-deploy the splines, after the spline got bent to the inside of the basket shape.The physician advance the sheath in order to retract the catheter.They checked outside the body and it seems ok.A new intellamap orion was used and the mapping was successfully completed.There were no patient complications reported.
 
Manufacturer Narrative
Investigation conclusion code updated from unintended use error caused or contributed to event to no problem detected.Visual inspection revealed no defects detected on the device.Functional testing revealed no opens or shorts.Hdx testing revealed that deployment can be seen on the work station screen without an issue and mapping capability was normal.The lcr testing revealed the boundaries were within specifications and matched the electrical test results.Diameter measurements were taken on different locations of the main shaft (tip, distal collar, 2 cm, 55 cm).The values fall into manufacturing standards, which passed the test.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
 
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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 Key9596308
MDR Text Key178214941
Report Number2134265-2020-00189
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,Followup
Report Date 04/03/2020
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 Date02/03/2021
Device Model Number87035
Device Catalogue Number87035
Device Lot Number0024215663
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/28/2020
Initial Date Manufacturer Received 12/19/2019
Initial Date FDA Received01/16/2020
Supplement Dates Manufacturer Received02/26/2020
03/27/2020
Supplement Dates FDA Received03/12/2020
04/03/2020
Patient Sequence Number1
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