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Catalog Number 5MAXACE132 |
Device Problem
Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/26/2024 |
Event Type
malfunction
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Event Description
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The patient was undergoing a thrombectomy procedure using a penumbra system ace 60 reperfusion catheter (ace60) and a stent retriever.During the procedure, when the physician removed the ace60 and the stent retriever together from the patient, it was found that the distal length of the ace60 was fractured.No additional information was provided regarding the completion of the procedure.There was no report of an adverse effect to the patient.
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Manufacturer Narrative
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This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.H3 other text : placeholder.
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Event Description
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The patient was undergoing a thrombectomy procedure in the m1 segment of the middle cerebral artery (mca) using a penumbra system ace 60 reperfusion catheter (ace60), a neuron max 6f 088 long sheath (neuron max), and a stent retriever.It should be noted that the patient''s anatomy was tortuous.During the procedure, after making many passes using the ace60 and the stent retriever, the physician experienced resistance while retracting the stent retriever out of the ace60.It was also reported that the physician experienced resistance while removing the ace60 and the stent retriever together from the patient.After removing the devices, the physician found that the distal length of the ace60 was fractured.The procedure was completed using the same neuron max, a non-penumbra catheter, and the same stent retriever.There was no report of an adverse effect to the patient.
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Manufacturer Narrative
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Please note that the following sections are being updated based on additional information provided by the distributor on 05/23/2024: 1.Section b.Box 5.Describe event or problem.1.Section h.Box 6.Evaluation codes: device code 2.Evaluation of the returned ace60 confirmed that the catheter was fractured.The complaint stated that resistance was experienced while retracting the ace60 and non-penumbra stent retriever together.If the ace60 is retracted against resistance, damage such as a fracture may occur.Further evaluation revealed a kink on the catheter shaft, and discoloration on the distal tip of the ace60.This damage was incidental to the reported complaint.The discoloration on the distal tip may have occurred due to tip shaping the catheter prior to the procedure.The kink likely occurred during packaging of the device for return to penumbra.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.H3 other text : placeholder.
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Search Alerts/Recalls
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