Model Number M0062101170 |
Device Problem
Material Rupture (1546)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/04/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported to boston scientific corporation that a nephromax balloon catheter was used during a percutaneous nephrolithotomy (pcnl) procedure preformed on (b)(6) 2016.According to the complainant, during the procedure and upon inflation, the balloon burst.The procedure was completed with another nephromax balloon catheter.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be fine with no additional pain.
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Manufacturer Narrative
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Visual examination of the returned nephromax balloon catheter revealed that the balloon had been subjected to positive pressure and deflated.An examination of the balloon material identified a longitudinal tear starting 1mm proximal of the distal markerband and extending 15mm proximally.There were no issues identified on the balloon material and the markerband which could potentially have contributed to the tear.The most probable root cause classification of this investigation is operational context.This is defined as a complaint that is associated with a product that meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.
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Event Description
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It was reported to boston scientific corporation that a nephromax balloon catheter was used during a percutaneous nephrolithotomy (pcnl) procedure preformed on (b)(6) 2016.According to the complainant, during the procedure and upon inflation, the balloon burst.The procedure was completed with another nephromax balloon catheter.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be fine with no additional pain.
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Search Alerts/Recalls
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