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Catalog Number RED72KIT |
Device Problems
Break (1069); Leak/Splash (1354); Suction Problem (2170)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/12/2022 |
Event Type
malfunction
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Event Description
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The patient was undergoing a thrombectomy procedure in the internal carotid artery (ica) using a penumbra system red 72 reperfusion catheter (red72) and a non-penumbra sheath.During the procedure, the physician advanced the red72 through the sheath into the target vessel and began aspiration using a 60ml syringe.During the second attempt, the physician was no longer able to aspirate because the syringe lost pressure.Subsequently, the red72 was removed.The physician then flushed the red72 and noticed that it was leaking and broken from the proximal end near the hub.Therefore, the red72 was no longer used procedure.The procedure was completed using a new red72 and the same non-penumbra sheath.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.
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Manufacturer Narrative
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Evaluation of the returned red72 confirmed that the catheter was fractured near the hub.If the red72 is inadvertently mishandled at an angle during use, damage such as a fracture may occur.During evaluation, the catheter was flushed, and a leak was observed at the fractured location.Further evaluation revealed kinks and ovalization along the catheter shaft.This damage was incidental to the reported complaint and the root cause of this damage could not be determined.Penumbra products are visually 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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