During preparation for a medical procedure, the hospital staff noticed that a penumbra system 3max reperfusion catheter (3maxc) was broken upon removal from the packaging.The damage to the 3maxc was found prior to use and, therefore, it was not used in the procedure.The procedure was completed using a new 3maxc.
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Results: the 3maxc was fractured approximately 59.0 cm from the hub.Yield marks were present on both sides of the fracture location.Conclusions: evaluation of the returned 3maxc confirmed a fractured device.If the 3maxc is forcefully retracted at an extreme angle during removal from its packaging, damage such as a kink may occur.If a kinked device is further manipulated, the kink may worsen to a fracture.Further evaluation revealed yield marks on both sides of the fracture site.This indicates that device was likely kinked prior to fracture.Penumbra catheters are visually inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.H3 other text : placeholder.
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