Results: the penumbra system 3max reperfusion catheter (3max) was fractured approximately 78.0 cm from the hub.Conclusions: evaluation of the returned devices revealed that the ace 68 was kinked.The location and type of damage on the ace 68 typically occurs when the tubing tray is not removed prior to withdrawing the ace 68 from the packaging shell.Further evaluation revealed that the 3max was fractured.This damage may have occurred due to forceful advancement of the 3max through the damaged ace 68.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.This report is associated with mfr report number: 3005168196-2017-00428.
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The patient was undergoing thrombectomy procedure using a penumbra system 3max reperfusion catheter (3max) and a penumbra system ace 68 hi-flow kit (kit).During the procedure, while attempting to advance the 3max into the penumbra system ace 68 reperfusion catheter (ace 68), the physician did not mention feeling any resistance; however, the 3max broke into two pieces.Therefore, the devices were removed and the procedure was completed using a new 3max and a new kit.It should be noted that there were no reported damages to the ace 68.Additionally, there was no report of an adverse effect to the patient.
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