Imperative Care—Zoom 71 Reperfusion Catheters: Distal End May Fracture and Detach

August 25, 2021 | Strategic Insights for Health System


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Problem: ​In an August 18, 2021, Urgent Voluntary Medical Device Recall letter submitted by ECRI member hospitals, Imperative Care states that the distal end of the above catheters may fracture and become detached, including but not limited to when the catheter is retracted against significant resistance or is retracted through a kinked guide catheter or other constraint. If the distal end becomes fractured, it may remain in the patient; this occurrence could lead to prolongation of the procedure, vascular injury, occlusion, stroke, or death as a result of any of the previous sequelae. This problem may also necessitate additional interventions, including but not limited to retrieval of fractured pieces, which, in turn, carries inherent risks. Imperative Care also states that through August 17, 2021, it has received eight reports associated with this problem; eight serious injuries and zero deaths have been reported. In four of the reported incidents, the fractured distal end was removed from the patient by...

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