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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During preparation for a thrombectomy procedure, the penumbra system 3max reperfusion catheter (3maxc) was fractured mid shaft, upon removal from the packaging; therefore, the 3maxc was not used in the procedure.The procedure was completed using a new 3maxc.
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