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 M004PM4500N40 |
Device Problem
Bent (1059)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/01/2015 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4) - the device has a kink at 12mm from the tip while in the neutral position (between ring 1 and 2).In addition the rings #1 and #2 has broken adhesive and fluids under them.The steering knob and the tension control knob functioned properly on both lock and unlock positions.The right and left curves are placed in the template shaded areas, the device passed the dimensional test.However, the device has a kink at the distal section.X ray analysis revealed that the center support is kinked.The distal section was dissected finding the center support kinked at 12 mm from the tip.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.(b)(4).
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Event Description
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Reportable based on analysis completed on 22july2015.It was reported that the catheter tip was bent.Upon removal of the intellatip mifi xp temperature ablation catheter it was noted that the tip was bent, this made the catheter difficult to manipulate.No patient complications were reported.However, analysis revealed broken adhesive between the electrodes.
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