During preparation for a medical procedure, a penumbra system 3max reperfusion catheter (3maxc) kinked while being removed from the packaging hoop.The damage to the 3maxc occurred 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 kinked approximately 83.5 cm from the hub.Conclusions: evaluation of the returned 3maxc confirmed a kink.If the device is forcefully mishandled while retracting from its packaging hoop, damage such as a kink may occur.Penumbra catheters are 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.
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