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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SAN JOSE INTELLAMAP ORION?; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
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BOSTON SCIENTIFIC - SAN JOSE INTELLAMAP ORION?; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING Back to Search Results
Model Number M004RC64S0
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/23/2015
Event Type  malfunction  
Event Description
It was reported that during an atrial fibrillation procedure, catheter spline detachment occurred.The target lesion was located in the left atrium.After verifying bilateral movement and proper spline deployment outside the patient, the intellamap orion¿ was inserted in usual fashion using the introducer tool.The left atrium was being mapped and the physician aggressively pulled the orion out of the body via the femoral vein through a long non-deflectable sheath with the orion fully deployed.The orion was inspected upon removal which showed partial spline detachment with no fragments or missing parts.A new orion was opened and the procedure was successfully completed with no patient complications.
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
Device evaluated by manufacturer - the device has a spline detached from the proximal end of the array.Moreover, evidence of adhesive was found at the array proximal end and inside the brown collar.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is user/use error, as complaint report states that the orion was withdrawn into the sheath with the splines fully deployed.(b)(4).
 
Event Description
It was reported that during an atrial fibrillation procedure, catheter spline detachment occurred.The target lesion was located in the left atrium.After verifying bilateral movement and proper spline deployment outside the patient, the intellamap orion¿ was inserted in usual fashion using the introducer tool.The left atrium was being mapped and the physician aggressively pulled the orion out of the body via the femoral vein through a long non-deflectable sheath with the orion fully deployed.The orion was inspected upon removal which showed partial spline detachment with no fragments or missing parts.A new orion was opened and the procedure was successfully completed with no patient complications.
 
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Brand Name
INTELLAMAP ORION?
Type of Device
CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
Manufacturer (Section D)
BOSTON SCIENTIFIC - SAN JOSE
150 baytech drive
san jose CA 95134
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 Key4718458
MDR Text Key5664269
Report Number2134265-2015-02144
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
Type of Report Initial,Followup
Report Date 03/23/2015
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 Date09/30/2015
Device Model NumberM004RC64S0
Device Catalogue NumberRC64S
Device Lot Number17557085
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/01/2015
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/29/2015
Initial Date FDA Received04/22/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received05/27/2015
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
Type of Device Usage Initial
Patient Sequence Number1
Patient Age64 YR
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