SPECTRANETICS CORPORATION TURBO-ELITE LASER ATHERECTOMY CATHETER; CATHETER, PERIPHERAL, ATHERECTOMY
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Model Number 414-159 |
Device Problem
Wrong Label (4073)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/21/2023 |
Event Type
malfunction
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Manufacturer Narrative
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A2-a5): device was not used in patient.B6-b7): device was not used in patient.D4): device serial number unk.H3/h6): the device has not been returned to the manufacturer at this time; therefore, conclusion is not yet available.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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Event Description
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During preparation for use, it was discovered that upon opening a box labeled with a spectranetics 1.4 turbo-elite laser atherectomy catheter, the box contained a 2.0 turbo-elite.The device was not used in the patient, and there was no reported injury.This report captures the labeling discrepancy that a larger size device was contained inside the box, potential for harm.
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Manufacturer Narrative
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D4): device serial number populated.D9): the device was returned to the manufacturer 06oct2023.G3): the device evaluation and investigation were completed 11oct2023.H3): the turbo-elite and packaging were returned.Visual inspection of the box label indicated a 1.4 size; however, the pouch inside the box indicated a 2.0 size.H6): based on the device evaluation and investigation, this has been determined to be a production process related failure that was inadvertently missed during the quality control inspection.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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Search Alerts/Recalls
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