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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 12/15/2020 |
Event Type
malfunction
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Event Description
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It was reported that the device became stuck on the guidewire.A 2.4mm jetstream xc was selected for use in an atherectomy and percutaneous transluminal angioplasty procedure in the left leg's superficial femoral artery.The 80% stenosed target lesion was moderately calcified and located in mildly tortuous anatomy.Prior to the procedure, the thruway guidewire was noted to be kinked, but it was used anyway.During insertion, the jetstream xc became stuck on the guidewire, and both devices had to be removed as a system.The procedure was completed with another of the same device.No patient complications were reported.The patient did fine post-procedure.
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Manufacturer Narrative
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Device eval by manufacturer: the product was returned to boston scientific for analysis.Returned product consisted of a jetstream xc-2.4.The guidewire was not in the device or returned with the device.The device and the catheter shaft were analyzed for damage.The catheter shaft showed multiple areas of buckling from the tip to proximal 47cm.A severe kink was noticed 1cm from the tip.The device was set up per the instructions for use and the device primed and functioned as designed.A 0.014 inch thruway test guidewire was inserted into the guidewire lumen of the device and the wire transcended through the shaft until it stopped approximately 43cm from the tip due to the shaft damage.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The complaint was confirmed for a restriction on the guidewire due to the damage on the catheter shaft.
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Event Description
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It was reported that the device became stuck on the guidewire.A 2.4mm jetstream xc was selected for use in an atherectomy and percutaneous transluminal angioplasty procedure in the left leg's superficial femoral artery.The 80% stenosed target lesion was moderately calcified and located in mildly tortuous anatomy.Prior to the procedure, the thruway guidewire was noted to be kinked, but it was used anyway.During insertion, the jetstream xc became stuck on the guidewire, and both devices had to be removed as a system.The procedure was completed with another of the same device.No patient complications were reported.The patient did fine post-procedure.
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Search Alerts/Recalls
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