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Model Number 45007 |
Device Problem
Material Split, Cut or Torn (4008)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/17/2019 |
Event Type
malfunction
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Event Description
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It was reported that outer sheath peeled.Two 2.1mm jetstream xc catheters were selected for an atherectomy procedure in the occluded superficial femoral artery.The occluded stent was pre-dilated with an unspecified 2.0 balloon.The first jetstream made it half way through the stent when it started to slow down.It was difficult to push the device outside the patient.The device kinked outside the patient.The device was removed.Subsequently, the lesion was pre-dilated with an unspecified 4.0 balloon.One pass was made with the second jetstream device with blades down, rex'd back and one pass with blades up, rex up.It was noted during the second pass blades up, that the outer coating of the catheter inside the patient, started to peel back.The device was not moving and the outer sheath peeled back.Rotaglide and a saline bag were used.The device was removed from the patient.The procedure was completed with a different device.No patient complications were reported and the patient's status is fine.
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Event Description
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It was reported that outer sheath peeled.Two 2.1mm jetstream xc catheters were selected for an atherectomy procedure in the occluded superficial femoral artery.The occluded stent was pre-dilated with an unspecified 2.0 balloon.The first jetstream made it half way through the stent when it started to slow down.It was difficult to push the device outside the patient.The device kinked outside the patient.The device was removed.Subsequently, the lesion was pre-dilated with an unspecified 4.0 balloon.One pass was made with the second jetstream device with blades down, rex'd back and one pass with blades up, rex up.It was noted during the second pass blades up, that the outer coating of the catheter inside the patient, started to peel back.The device was not moving and the outer sheath peeled back.Rotaglide and a saline bag were used.The device was removed from the patient.The procedure was completed with a different device.No patient complications were reported and the patient's status is fine.
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Manufacturer Narrative
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Device evaluated by mfr: returned product consisted of a jetstream xc-2.1 atherectomy catheter.The shaft and the remainder of the device was inspected for damage.Visual examination showed 2 kinks and buckling.The kinks were located 85.5cm and 88cm from the tip.The buckling was located 1.5cm from the tip.The functionality of the device was checked by setting up the product per the directions for use.The device primed, and the device functioned as designed.The kinks and the buckling of the shaft are consistent with interaction with another device such as an introducer sheath.Pushing, pulling and torqueing the device may cause this kind of damage.The peeling back of the of the outer sheath the customer described may have been the buckling notice at the tip of the device.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.
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Search Alerts/Recalls
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