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Catalog Number RED72KIT |
Device Problem
Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/25/2023 |
Event Type
malfunction
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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.
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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), and a penumbra engine (engine).During the procedure, the physician turned on the engine and the red72 was aspirating air.It was noted the red72 was fractured at the hub.Therefore, the red72 was removed.No additional information regarding the procedure was provided.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 a fracture near the hub, underneath the strain relief.This damage typically occurs if the device is manipulated at angles during use.Based on the reported complaint, the root cause of the fracture could not be determined.The red72 leaked from the fractured location during evaluation.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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