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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 Activation, Positioning or Separation Problem (2906)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/06/2014
Event Type  malfunction  
Event Description
It was reported that the safety button detached.The intellamap orion mapping catheter was tested accordingly outside the body for deployment and articulation of the curve.The device was then prepped and inserted into the left atrium.Shortly thereafter, the safety button popped out, requiring the physician to press it back in to undeploy or deploy the basket.It was also noted that there was a bent space near the neutral position of the steering, and a "hitch" at the pole articulation in one direction.The physician completed the procedure with a new orion catheter.There were no patient complications reported.
 
Event Description
It was reported that the safety button detached.The intellamap orion mapping catheter was tested accordingly outside the body for deployment and articulation of the curve.The device was then prepped and inserted into the left atrium.Shortly thereafter, the safety button popped out, requiring the physician to press it back in to undeploy or deploy the basket.It was also noted that there was a bent space near the neutral position of the steering, and a "hitch" at the pole articulation in one direction.The physician completed the procedure with a new orion catheter.There were no patient complications reported.
 
Manufacturer Narrative
(b)(4).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: the device was returned with the safety button detached.Functional inspection revealed that the device passes the curving and deployment/un-deployment test.The handle was opened and the safety button was found completely detached.There is evidence of adhesive in two points inside the component, however it is broken.In addition a spike shape was found in the safety button tap.The batch number is unknown and the manufacturing records for the complaint device could not be reviewed.The root cause of the reported difficulties could not be determined.(b)(4).
 
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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 - COSTA RICA (COYOL)
2546 first street
propark free zone
alajuela
CS  
Manufacturer Contact
linda leimer
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key4251039
MDR Text Key5017471
Report Number2134265-2014-07375
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 Physician
Remedial Action Other
Type of Report Initial,Followup
Report Date 11/06/2014
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 NumberM004RC64S0
Device Catalogue NumberRC64S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/14/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/28/2014
Initial Date FDA Received11/14/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received12/17/2014
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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