Model Number 45007 |
Device Problem
Entrapment of Device (1212)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/10/2018 |
Event Type
malfunction
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Event Description
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It was reported that a device became stuck on a wire.A 2.4 mm jetstream xc catheter was selected for an atherectomy procedure in the left superficial femoral artery.At the end of the procedure during removal of the device, the jetstream because stuck on a non-bsc wire.Both the jetstream and non-bsc wire were able to be removed without complication.The patient experienced no harm or adverse events.
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Event Description
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It was reported that a device became stuck on a wire.A 2.4 mm jetstream xc catheter was selected for an atherectomy procedure in the left superficial femoral artery.At the end of the procedure during removal of the device, the jetstream because stuck on a non-bsc wire.Both the jetstream and non-bsc wire were able to be removed without complication.The patient experienced no harm or adverse events.
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Manufacturer Narrative
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Device eval by manufacturer: returned product consisted of a jetstream xc-2.4 atherectomy catheter with a.014 nav 6 filter wire stuck in the device.The device and the catheter shaft were analyzed for damage.Visual analysis showed 1 kink on the catheter shaft located 101.5cm from the tip.Functionality was completed by connecting the device to the jetstream console.The device functioned as designed.The customer stated that a nav 6 filter wire was used for this procedure which is not on the compatible guidewire list per the dfu.Microscopic analysis of the tip area showed that the device had been run over the coils of the guidewire.When the device is run too far distal and interference with the coils results, this could contribute to the guidewire sticking issues the customer experienced.Inspection of the remainder of the device, revealed no damage or irregularities.
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Search Alerts/Recalls
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