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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) INTELLAMAP ORION?; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
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BOSTON SCIENTIFIC - COSTA RICA (COYOL) INTELLAMAP ORION?; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING Back to Search Results
Model Number M004RC64S0
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/03/2015
Event Type  malfunction  
Event Description
An intellamap orion catheter was selected; however, during the saline bowl rinse after the orion was used inside the body, an unknown substance was spotted in the bowl.The particle was collected in formalin and ready for examination.No patient complications were reported.The procedure was completed with this device.
 
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.(b)(4).
 
Manufacturer Narrative
Device evaluated by manufacturer: examination of the returned complaint device revealed no visual defects.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause was unable to be determined.(b)(4).
 
Event Description
An intellamap orion catheter was selected; however, during the saline bowl rinse after the orion was used inside the body, an unknown substance was spotted in the bowl.The particle was collected in formalin and ready for examination.No patient complications were reported.The procedure was completed with this device.
 
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Brand Name
INTELLAMAP ORION?
Type of Device
CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
Manufacturer (Section D)
BOSTON SCIENTIFIC - COSTA RICA (COYOL)
2546 first street
propark free zone
alajuela
CS 
Manufacturer (Section G)
BOSTON SCIENTIFIC - SAN JOSE
150 baytech drive
san jose CA 95134
Manufacturer Contact
linda leimer
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key4632799
MDR Text Key18039663
Report Number2134265-2015-01673
Device Sequence Number1
Product Code DRF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K122461
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 03/03/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/25/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/30/2015
Device Model NumberM004RC64S0
Device Catalogue NumberRC64S
Device Lot Number17557085
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/24/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/05/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/20/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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