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Catalog Number PCE050040130 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 04/17/2018 |
Event Type
Injury
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Manufacturer Narrative
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Evaluation summary: the catheter was full of blood.The catheter returned broken with the distal part missing: the balloon with tip and the distal marker.Only the proximal part of the catheter with hub, shaft and the proximal marker still crimped on the guidewire tube returned.The detachment between balloon and shaft happened at the proximal balloon welding.Even with the distal part missing, it was possible to load the 0,018 guidewire from the hub.Image evaluation: two pictures were received showing the catheter in vitro after use.The device is dirty of blood and the balloon was not present.The distal marker was not visible.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Physician intended to use a pacific plus with a non-medtronic 6f sheath and non-medtronic inflation device for the treatment of a moderately calcified non-tortuous lesion in the distal superficial femoral artery (sfa) following initial treatment of the occlusion using a non-mdt device.Device was prepped as per ifu without issue.The device did not pass through a previously deployed stent, no resistance was encountered during advancement but excessive force during withdrawal was reported.It is reported that a part of the balloon material was detached when the balloon catheter was removed from the introducer sheath.The physician attempted to retrieve the detached balloon material, unsuccessfully.Physician then attempted to push the material to the vessel wall, but it was already displaced to a side branch of the gluteal artery by the blood flow.The stenosis in the sfa was treated with 3 non-medtronic stents.
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Search Alerts/Recalls
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