The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
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The patient was undergoing a medical procedure in the left middle cerebral artery (mca) using a benchmark 6f 071 delivery catheter (benchmark) and non-penumbra sheath.During the procedure, while advancing a benchmark over a wire and into the sheath, the mid-shaft of the benchmark fractured.Therefore, the benchmark was removed.The procedure was completed using another benchmark and the same sheath and wire.There was no report of an adverse effect to the patient.
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