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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 Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/22/2024
Event Type  malfunction  
Event Description
It was reported that during an atrioventricular reentrant tachycardia procedure an intellamap orion catheter was selected for use.During mapping in the left atrium, the catheter started to blink and it was not possible to get the map.The physician decided to removed the catheter and found that a spline was physically detached from the distal end.The catheter was replaced and the procedure was completed successfully.No patient complications were reported.The device is expected to return for laboratory analysis.
 
Manufacturer Narrative
The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
 
Manufacturer Narrative
Intellamap orion catheter was evaluated by boston scientific.Visual inspection found the device has a spline detached, consequently confirming the reported event, and it may be related with some other factors such as: handling of the device, the technique used by the physician and normal procedural difficulties encountered during the procedure that could have possibly affected the device performance and its integrity.Therefore, this investigation is assigned a conclusion code of "adverse event related to procedure" which indicates that the adverse event occurred during the procedure and the device had no influence on the event.
 
Event Description
It was reported that during an atrioventricular reentrant tachycardia procedure an intellamap orion catheter was selected for use.During mapping in the left atrium, the catheter started to blink and it was not possible to get the map.The physician decided to removed the catheter and found that a spline was physically detached from the distal end.The catheter was replaced and the procedure was completed successfully.No patient complications were reported.The device has been received at boston scientific post market laboratory.
 
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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 Key18596700
MDR Text Key334611268
Report Number2124215-2024-04542
Device Sequence Number1
Product Code DRF
UDI-Device Identifier08714729841968
UDI-Public08714729841968
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K143481
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/22/2024
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 Model Number87035
Device Catalogue Number87035
Device Lot Number0032089328
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/22/2024
Initial Date FDA Received01/29/2024
Supplement Dates Manufacturer Received02/21/2024
Supplement Dates FDA Received03/22/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/26/2023
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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