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Model Number 45007 |
Device Problems
Difficult to Advance (2920); Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/28/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Device evaluated by manufacturer: the device returned to boston scientific consisted of a jetstream xc-2.4 atherectomy catheter.The device was visually and microscopically examined for any damage.Visual examination showed multiple catheter shaft damage in the form of buckling.The device showed a burst infusion sheath 21.8cm from the strain relief.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.
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Event Description
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It was reported that infusion line material deformation occurred.A jetstream xc catheter was prepared, and once inside the patient's body, the catheter was hard to advance.They noticed the outside of the catheter started to buckle.Eventually the priming liquid was squirting out of the catheter.A new device was used to complete the case with no complications.
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Search Alerts/Recalls
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