Model Number H74939282202010 |
Device Problem
Device Markings/Labelling Problem (2911)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/03/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Age at time of event: 18 years or older.(b)(4).
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Event Description
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It was reported that balloon marker band misalignment occurred.The 99% stenosed target lesion was located in the moderately tortuous and moderately calcified left iliac artery.A 2.0mmx20mmx143cm nc quantum apex¿ balloon catheter was advanced for dilation.However, during initial inflation for 60 seconds, it was observed under fluoroscopy that the positional relation between balloon marker and the balloon appeared to be different from normal.The usage of this device was discontinued and the procedure was completed with sterling balloon catheter.No patient complications were reported and the patient's status was good.
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Manufacturer Narrative
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Device evaluated by mfr: returned product consisted of a nc quantum apex balloon catheter.There was contrast in the inflation lumen.The balloon, balloon bonds and markerbands were examined.The proximal markerband was located 12mm from the distal markerband.Microscopic examination revealed indentations on the inner shaft aligned with the proximal balloon cone, which indicates that the markerband was placed correctly prior to inflation.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion was unable to be determined.(b)(4).
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Event Description
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It was reported that balloon marker band misalignment occurred.The 99% stenosed target lesion was located in the moderately tortuous and moderately calcified left iliac artery.A 2.0mmx20mmx143cm nc quantum apex balloon catheter was advanced for dilation.However, during initial inflation for 60 seconds, it was observed under fluoroscopy that the positional relation between balloon marker and the balloon appeared to be different from normal.The usage of this device was discontinued and the procedure was completed with sterling balloon catheter.No patient complications were reported and the patient's status was good.
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Search Alerts/Recalls
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