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Model Number 45007 |
Device Problems
Leak/Splash (1354); Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/16/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Device evaluation by manufacturer: the device returned to boston scientific consisted of a jetstream xc-2.1 atherectomy catheter.The device was visually examined for any shaft damage.Visual analysis showed shaft damage located 1cm and 90.5cm from the tip.The infusion line showed a burst located 98.5cm from the tip.The device was set up per the instructions for use (ifu) and the device ran as designed.There was a leak noticed at the 98.5cm location.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.Device analysis determined the condition of the returned device was consistent with the reported information.The complaint for material deformation, kinks, and a fluid leak were confirmed.
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Event Description
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It was reported that an infusion line leak occurred.A 2.1mm jetstream xc atherectomy catheter was selected for an atherectomy procedure to treat peripheral arterial disease.The superficial femoral artery had been treated successfully; however, when moving distally to the popliteal and posterior tibial trunk, a catheter leak was noticed.There were no patient complications, and an eluvia was placed in the superficial femoral artery.Plain old balloon angioplasty was used to treat the distal portion to complete the procedure.
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Search Alerts/Recalls
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