Catalog Number RED72SDKIT |
Device Problems
Fracture (1260); Stretched (1601)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/21/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The device has been returned and the investigation results are pending.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 using a penumbra system red 72 reperfusion catheter (red72), a sendit delivery device (sendit), and a neuron max 6f 088 long sheath (neuron max).During the procedure, it was reported that the distal end of the red72 was stretched and then fractured while inside the patient.Therefore, the red72 was removed.The procedure was completed using a penumbra system red 68 reperfusion catheter (red68).There was no report of an adverse effect to the patient.
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Manufacturer Narrative
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Evaluation of the returned red72 confirmed that the catheter was fractured and stretched near the fractured location.If the red72 is retracted against resistance, damage such as stretching and subsequent fracture may occur.Further evaluation revealed a kink on the catheter shaft.This damage was incidental to the reported complaint and may have 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.
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Search Alerts/Recalls
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