Model Number H74939186401010 |
Device Problem
Break (1069)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/27/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Bsc id: (b)(4).Tw: (b)(4).
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Event Description
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It was reported that shaft break occurred.The target lesion was located in the tibial artery.A 4.0mm x 100mm x 150cm coyote¿ balloon catheter was advanced to dilate the lesion.However, during introduction, it was noted that the hypotube was detached and the physician did not reach to put the balloon into the patient.A sterling balloon catheter was used and completed the procedure.No patient complications were reported and the patient's status was excellent.
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Manufacturer Narrative
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Device evaluated by mfr.: returned product consisted of a coyote balloon catheter.The balloon is loosely folded with contrast in the lumen and blood in the guidewire lumen and blood on the outside of the balloon.Although it was reported that the device was not used, the presence of blood and contrast media in the guidewire lumen is indicative of handling beyond simply unpackaging the device, as was reported.The hypotube and shaft was microscopically examined.The outer shaft is separated/torn 3mm from the hub.The fractured/separated end of the distal shaft is stretched and jagged which indicates the shaft separation was due to tensile forces.There is a hole in the outer shaft next to the separation.The inner shaft is buckled in numerous locations which is consistent with the damage seen with the use of a guidewire.The tip is damaged.There was no evidence of any material or manufacturing deficiencies contributing to the damage and the reported difficulty.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 shaft break occurred.The target lesion was located in the tibial artery.A 4.0mm x 100mm x 150cm coyote¿ balloon catheter was advanced to dilate the lesion.However, during introduction, it was noted that the hypotube was detached and the physician did not reach to put the balloon into the patient.A sterling balloon catheter was used and completed the procedure.No patient complications were reported and the patient's status was excellent.
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Search Alerts/Recalls
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