BOLTON MEDICAL, INC. RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM; STENT, ENDOVASCULAR GRAFT, AORTIC,
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Catalog Number 28-M338145382490U |
Device Problems
Bent (1059); Retraction Problem (1536); Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/14/2014 |
Event Type
malfunction
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Manufacturer Narrative
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"during an internal audit, it was determined that complaints for similar devices, and device malfunctions that have the potential to harm the patient if they were to recur, were not reported as per fda guidance.After retrospective review, this event is determined to be mdr reportable.".
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Event Description
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When starting deployment in position 2, physician feel strong force from grey handle and inner sheath was not retract and tips was bending.So change to position "4" and hold the stainless steel rod and retract the deployment grip to deploy the device.
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Search Alerts/Recalls
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