BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) INTELLATIP MIFI? XP TEMPERATURE ABLATION CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
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Model Number M004PM4500K20 |
Device Problem
Bent (1059)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/05/2015 |
Event Type
malfunction
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Event Description
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Same case as mfr id # 2134265-2015-02751.Reportable based on analysis completed on (b)(4) 2015.It was reported that tip damage occurred.The target lesion was located in the right atrium.During use of the intellatip mifi¿ xp temperature ablation catheter, the physician noted that the tip was bent between the second and third electrode.This occurred with a second intellatip mifi¿ xp temperature ablation catheter as well.The procedure was completed with a non-bsc catheter.However, analysis revealed that the adhesive between the electrodes was broken.
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Manufacturer Narrative
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Device evaluated by manufacturer - the device has a kink at the distal section while in the neutral position at 14mm from the tip.All the rings have broken adhesive and fluids under them.Both curves are not placed in the template shaded areas, the device failed the dimensional test.The handle was opened, and no issues were detected in that section.The device was dissected finding the guide coil collapsed in 3 section at 3cm, 8.5cm and 10cm.The distal section was dissected finding the center support broken at 14mm from the tip.In addition the steering wires are kinked in the same area.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.The most probable root cause was unable to be determined.(b)(4).
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