BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) BLAZER PRIME® XP; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
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Model Number M004P4500THK20 |
Device Problem
Bent (1059)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/12/2015 |
Event Type
malfunction
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Event Description
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Same case as mdr id: 2134265-2015-03689.Reportable based on device analysis completed on (b)(4) 2015.It was reported that a catheter tip bent occurred.The target lesion was located in the right atrium.A 7-110-2.5-8-8 k2 blazer prime® xp and a was selected to treat the target lesion.During the procedure, it was noted by the physician that both catheter's tip were bent.The procedure was completed with another of the same device.No patient complications reported and the patient's status was fine.However, device analysis revealed broken adhesive at ring# 1 and #2.
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Manufacturer Narrative
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(b)(4).Device evaluated by mfr., the device was returned for analysis.The device has a kink at 13mm from the tip while in the neutral position (between ring 1 and 2).In addition the ring#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.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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