SPECTRANETICS CORPORATION TURBO-ELITE LASER ATHERECTOMY CATHETER; CATHETER, PERIPHERAL, ATHERECTOMY
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Model Number 410-152 |
Device Problems
Material Separation (1562); Material Integrity Problem (2978)
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Patient Problem
Unintended Radiation Exposure (4565)
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Event Date 08/01/2023 |
Event Type
malfunction
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Event Description
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A peripheral atherectomy procedure commenced, and a spectranetics turbo-elite laser atherectomy catheter was used to treat the patient.Initial calibration of the catheter went smoothly and performed normally.Upon removal, flaking was reported at the tip of the catheter.Use of the catheter was discontinued, and another laser catheter was used to complete the procedure with no reported patient harm.During initial device evaluation, a missing portion of the outer jacket was noted, and exposed fibers were present in the area.The evaluation and investigation are currently ongoing.This event is being reported for unintended radiation exposure, potential for harm.
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Manufacturer Narrative
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H3/h6): the device was returned to the manufacturer and the evaluation is currently ongoing.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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G3): the device evaluation and investigation was completed on 17jan2024.H3): the turbo-elite was returned for evaluation.Visual inspection found the outer jacket was ripped and missing, beginning at the fuse (where the distal marker band meets the outer jacket), extending proximally along the distal 2 inches of the catheter.There were no sharp edges along the length of the catheter, including the distal tip and the area surrounding the ripped and missing outer jacket.Additionally, the outer jacket showed no signs of melting or charring, and no broken fibers were detected.The distal marker band was present at the distal tip.H6): based on the device evaluation and investigation, the cause of the device damage could not be established.Investigation findings code edited to 3243 (from 3211).Investigation conclusions codes edited to 4315 (from 11).All other codes remain applicable as listed in the initial mdr.Additional information confirmed there was no patient harm due to the missing material observed during the device evaluation.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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