Device Problems
Break (1069); Appropriate Term/Code Not Available (3191)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/31/2021 |
Event Type
malfunction
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Event Description
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It was reported that the sheath was broken.A synergy megatron drug eluting balloon expandable stent guide sheath was broken.No patient complications were reported.
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Manufacturer Narrative
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H6: device codes: updated.
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Event Description
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It was reported that the sheath was broken.A synergy megatron drug eluting balloon expandable stent guide sheath was broken.No patient complications were reported.It further reported that the device was not a synergy megatron device.It was non boston scientific device that malfunctioned and it was confirmed that there was no allegation against the synergy megatron device.
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Search Alerts/Recalls
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