SPECTRANETICS CORPORATION TURBO-POWER LASER ATHERECTOMY CATHETER; CATHETER, PERIPHERAL, ATHERECTOMY
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Model Number 420-050 |
Device Problem
Material Separation (1562)
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Patient Problem
Unintended Radiation Exposure (4565)
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Event Date 10/17/2023 |
Event Type
malfunction
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Event Description
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A peripheral atherectomy procedure commenced to treat a moderately calcified, fibrous lesion in the mid pedal artery.A spectranetics turbo-power laser atherectomy catheter was used to treat the patient.During the procedure, laser light was observed emitting from the mid portion of the catheter shaft.Use of the turbo-power was discontinued and another catheter was used to successfully complete the procedure with no reported patient harm.This event is being reported for unintended radiation exposure, potential for harm.
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Manufacturer Narrative
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B6): relevant tests/laboratory data unk.B7): other relevant history unk.H3/h6): the device was returned to the manufacturer but the evaluation has not yet begun.A supplemental mdr will be submitted upon completion of the device evaluation and investigation.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.
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Manufacturer Narrative
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D9): correction: the suspect device was not returned for evaluation.G3): on 26oct2023, it was discovered the incorrect device was returned to the manufacturer.The suspect device was inadvertently discarded.H3): the suspect device was discarded, thus no investigation could be completed.H6): since the incorrect device was returned, no evaluation was performed, and the reported complaint could not be confirmed.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.
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