Model Number H74939202100540 |
Device Problems
Fracture (1260); Hole In Material (1293)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/03/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that the microcatheter became fractured and a balloon damage occurred.The target lesion was located in the mildly tortuous and moderately calcified distal superior femoral artery.An offroad¿ re-entry device was selected for use.The device was placed over the wire and was advanced halfway into the lesion.Then, the microcatheter lancet was placed through the balloon catheter and fractured inside the balloon catheter.The balloon was checked to ensure the fracture pieces were removed and balloon damage was noted.Everything was removed out of the patient's body.No patient complications were reported and the patient's status was stable.
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Manufacturer Narrative
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Device evaluated by manufacturer: the device was returned for analysis.Received for analysis was the microcatheter and the balloon catheter.The microcatheter was received in two sections, due to a break in the shaft.The break was located at 52.1cm distal to strain relief base in the hub.Both sections of the shaft were kinked at various locations along its length.A visual examination identified that the inner wall lining of the microcatheter was severely stretched and it extended out from the proximal end of the shaft break, measuring 56.2cm from the break site.No issues were noted with the tip stylet.The outer diameter of the microcatheter was measured at 0.031¿.This is within offroad micro catheter product specification.No issues were noted with the balloon catheter.A 0.035 inch guidewire was inserted through the balloon catheter with no restrictions noted and the balloon was inflated to rated burst pressure 3.25 atmospheres with no leaks or drop in pressure noted as per offroad balloon catheter product specification.The inflation device was verified at 3.25 atmospheres (atm) before and after use with a calibrated pressure gauge.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).
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Event Description
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It was reported that the microcatheter became fractured and a balloon damage occurred.The target lesion was located in the mildly tortuous and moderately calcified distal superior femoral artery.An offroad re-entry device was selected for use.The device was placed over the wire and was advanced halfway into the lesion.Then, the microcatheter lancet was placed through the balloon catheter and fractured inside the balloon catheter.The balloon was checked to ensure the fracture pieces were removed and balloon damage was noted.Everything was removed out of the patient's body.No patient complications were reported and the patient's status was stable.
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Search Alerts/Recalls
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