The devices were not returned for evaluation.Without return of the units it is not possible to determine if some damage or defect existed on the units that could have contributed to the event.It is not known if some procedural factors may have contributed to the event.No corrective actions will be taken at this time.Lot number was not provided; therefore, review of the manufacturing records could not be completed.Four cases of complications occurring in the fogarty catheter group were captured in mdr's 2015691-2020-13605 and 2015691-2020-13607.Fogarty adherent clot catheter is indicated for the removal of emboli and thrombi from either native vessels or synthetic grafts in the arterial system.To minimize the risk of vessel or membrane damage, the maximum recommended pull force for the catheter should not be exceeded.The instructions for use of the product contains the following statement: ¿as with all catheterization procedures, complications may occur.These may include local or systemic infection, local hematomas, intimal disruption, arterial dissection, perforation and vessel rupture, hemorrhage, arterial thrombolysis, distal emboli or blood clots or arteriosclerotic plaque, air emboli, aneurysms, arterial spasms, arteriovenous fistula formation, membrane separation and distal embolization.¿ complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.Yang, yu sung, et al."clinical experience with a hybrid procedure using the adherent clot catheter for salvage of thrombosed hemodialysis access: a comparison with the standard fogarty balloon catheter." vascular specialist international 31.1 (2015): 25.
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It was reported that in a journal article published in 2015 titled ¿clinical experience with a hybrid procedure using the adherent clot catheter for salvage of thrombosed hemodialysis access: a comparison with the standard fogarty balloon catheter¿.The study compared the efficacy of an adherent clot (ac) catheter to the standard balloon fogarty catheter for clot removal in thrombosed hemodialysis access.In the ac catheter group, 12 ruptures occurred: 3 events with venous outlet rupture solved by balloon angioplasty, 3 graft ruptures that were solved by primary closure and 6 fistula ruptures that were solved by patchy angioplasty.Additionally, distal thrombus embolization occurred in 2 cases and obstruction in 3 cases.Model and lot numbers are unknown.As well as any specific patient demographics.The devices were not saved for examination.
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