The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.
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During preparation for a medical procedure, the hospital staff noticed that the proximal end of a penumbra system 3max reperfusion catheter (3maxc) was kinked upon removal from packaging hoop.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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