BOSTON SCIENTIFIC CORPORATION ROTAWIRE AND WIRECLIP TORQUER; CATHETER, CORONARY, ATHERECTOMY
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Model Number 3520 |
Device Problem
Fracture (1260)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 11/02/2023 |
Event Type
Injury
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Event Description
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It was reported that the fractured device was left in the patient and the procedure was cancelled.A rotawire 330cm and burr were selected for use.During the procedure, due to vessel tortuousity, the burr debulked the rotawire, then the wire broke and 5cm of the wire left in the vessel.A loop was used to retrieve the wire, but it was very difficult to retrieve the wire.The complaint was not completed due to this event.
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Manufacturer Narrative
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H6 evaluation conclusion codes: corrected.
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Event Description
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It was reported that the fractured device was left in the patient and the procedure was cancelled.A rotawire 330cm and burr were selected for use.During the procedure, due to vessel tortuousity, the burr debulked the rotawire, then the wire broke and 5cm of the wire left in the vessel.A loop was used to retrieve the wire, but it was very difficult to retrieve the wire.The complaint was not completed due to this event.The physician arranged for surgery to be performed to remove the wire from the vessel.
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