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 06/08/2015 |
Event Type
malfunction
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Manufacturer Narrative
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Age at time of event: 18 years or older.(b)(4).Device evaluated by manufacturer - the device has a kink at 13mm 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 13 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 (b)(6) 2015.It was reported that the catheter was deformed.While performing a right atrial ablation, the distal tip of the intellatip mifi xp temperature ablation catheter became malformed.It appears that the steering mechanism of the catheter broke.The distal tip would not actively respond to straightening.The catheter was removed from the body multiple times in an effort to straighten the curve.Ultimately, the catheter was replaced with another intellatip mifi xp catheter and the case was completed.No patient complications were reported.However, analysis revealed broken adhesive between the electrodes.
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