THE SPECTRANETICS CORPORATION SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER; CATHETER, PERIPHERAL, ATHERECTOMY
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Model Number 410-152 |
Device Problem
Mechanical Jam (2983)
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Patient Problem
Radiation Exposure, Unintended (3164)
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Event Date 09/16/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Device evaluation: the device was returned to the manufacturer, and was evaluated on 1 oct 2020 by a cross functional team.A 0.014 guidewire was fed through both the distal tip, and proximal end without issue.The device was patent the entire working length.The team was unable to replicate the patency complaint.However, an obvious breach to the outer jacket was seen 5cm from the distal tip, and extended 11cm towards the proximal end.No broken fibers were seen in the area of the breach.However, this evaluation now makes this event reportable due to the potential for exposure to manufacturing materials as well as inadvertent exposure to laser energy/radiation.
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Event Description
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A peripheral atherectomy procedure commenced, indication for procedure unavailable but information was requested.The physician chose to use a spectranetics turbo elite laser atherectomy catheter to treat the patient.Initially, the complaint was that the device would not advance over a viper wire.A second turbo elite device was used to successfully complete the procedure with no reported patient harm.However, when the turbo elite catheter was returned to the manufacturer, and evaluated on 01 oct 2020, it was discovered that there was a breach in the device's outer jacket.This event is being reported due to the potential for exposure to manufacturing materials as well as inadvertent exposure to laser energy/radiation.
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Search Alerts/Recalls
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