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Catalog Number BMK6F95BER120 |
Device Problems
Break (1069); Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/19/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Evaluation of the returned benchmark confirmed that the catheter was damaged on its proximal end and was leaking.Evaluation revealed a kink on the proximal end of the catheter near the hub, and a hole was present underneath the strain relief.If the device is handled at an angle during use, damage such as this may occur.Further evaluation revealed bends and ovalizations along the catheter shaft.This damage was not mentioned in the complaint and is likely incidental and may have occurred during packaging 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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Event Description
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The patient was undergoing a medical procedure using a benchmark 6f 071 delivery catheter (benchmark) and a non-penumbra sheath.During the procedure, the physician advanced the benchmark to the target location and noticed that the benchmark was damaged at the proximal end.It was reported that the benchmark was leaking at the hub.Therefore, the benchmark was removed.The procedure was completed using another benchmark and the same sheath.There was no report of an adverse effect to the patient.
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Search Alerts/Recalls
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