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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTELLANAV OI
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BOSTON SCIENTIFIC CORPORATION INTELLANAV OI Back to Search Results
Model Number 87045
Device Problem Temperature Problem (3022)
Patient Problem Insufficient Information (4580)
Event Date 05/24/2021
Event Type  malfunction  
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.
 
Event Description
It was report that a intellanav oi was used in a ablation procedure.It was noted that it was not possible to ablate as the temperature was high and unstable.The catheter was replaced and the procedure was completed.No patient complications were reported.
 
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Brand Name
INTELLANAV OI
Type of Device
INTELLANAV OI
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 Key11946415
MDR Text Key254519894
Report Number2134265-2021-07313
Device Sequence Number1
Product Code OAE
Combination Product (y/n)N
Reporter Country CodeTU
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 06/07/2021
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 Date06/10/2023
Device Model Number87045
Device Catalogue Number87045
Device Lot Number0025584758
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/24/2021
Initial Date FDA Received06/07/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/10/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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