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Catalog Number BMK6F95MBER120 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/18/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Evaluation of the returned benchmark confirmed a leak near the hub.Evaluation revealed kink in the strain relief and a puncture at the kinked location.If the benchmark is advanced at an angle, damage such as a kink may occur.The damage likely contributed to the reported leak near the hub.During evaluation, the benchmark was flushed with a syringe and a leak was observed near the hub.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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Event Description
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The patient was undergoing a coil embolization middle meningeal artery (mma) using a benchmark 6f 071 delivery catheter (benchmark), a non-penumbra catheter, and a guidewire.During the procedure, the physician gained access to the left common carotid using a non-penumbra catheter through the benchmark.After gaining access, the physician removed the non-penumbra catheter and noticed that blood was leaking near the hub.Therefore, the benchmark was removed and was not used for the remainder of the procedure.The procedure was completed using another benchmark.There was no report of an adverse effect to the patient.
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Search Alerts/Recalls
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