BOSTON SCIENTIFIC CORPORATION JETSTREAM XC ATHERECTOMY CATHETER; CATHETER, PERIPHERAL, ATHERECTOMY
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Model Number 45007 |
Device Problem
Entrapment of Device (1212)
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Patient Problem
Embolism (1829)
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Event Date 09/27/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(6).
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Event Description
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It was reported that the catheter became stuck on the wire and some distal embolization occurred.A 2.4mm jetstream xc atherectomy catheter was selected for an atherectomy procedure in the superficial femoral artery (sfa) and the popliteal artery.During the procedure, the physician inserted a non-bsc filterwire and also a non-bsc guidewire.Then the jetstream device was placed.After some minutes of atherectomy, the jetstream catheter became stuck with the guidewire.They had to remove the jetstream catheter from the patient with an open filter.Some distal embolization occurred.No other patient complications were reported.Device evaluated by mfr: the returned product consisted of a jetstream xc-2.4 atherectomy catheter with a filter wire stuck in the device.The device and the catheter shaft were analyzed for damage.Visual analysis showed that the device presented no damage.The device tip was disconnected from the shaft.The bushing inside of the tip showed that the device had peeled the coating off during the procedure and caused the bushing to occlude with coating and seize the wire in the device.Functionality was completed by connecting the device to the jetstream console.The device ran as designed with no issues or errors.Inspection of the remainder of the device, revealed no damage or irregularities.It was noticed per the customers returned statement that the guidewire used during the procedure was a non-bsc filter wire.This wire is not on the compatible guidewire list.
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Manufacturer Narrative
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Age at time of event:18 years or older.(b)(6).
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Event Description
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It was reported that the catheter became stuck on the wire and some distal embolization occurred.A 2.4mm jetstream xc atherectomy catheter was selected for an atherectomy procedure in the superficial femoral artery (sfa) and the popliteal artery.During the procedure, the physician inserted a non-bsc filterwire and also a non-bsc guidewire.Then the jetstream device was placed.After some minutes of atherectomy, the jetstream catheter became stuck with the guidewire.They had to remove the jetstream catheter from the patient with an open filter.Some distal embolization occurred.No other patient complications were reported.Device evaluated by mfr: the returned product consisted of a jetstream xc-2.4 atherectomy catheter with a filter wire stuck in the device.The device and the catheter shaft were analyzed for damage.Visual analysis showed that the device presented no damage.The device tip was disconnected from the shaft.The bushing inside of the tip showed that the device had peeled the coating off during the procedure and caused the bushing to occlude with coating and seize the wire in the device.Functionality was completed by connecting the device to the jetstream console.The device ran as designed with no issues or errors.Inspection of the remainder of the device, revealed no damage or irregularities.It was noticed per the customers returned statement that the guidewire used during the procedure was a non-bsc filter wire.This wire is not on the compatible guidewire list.It was further reported that a special catheter was used to remove the embolism and the lesion was dilated with a below the knee (btk) balloon.The patient was noted to be fine post procedure.
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