Additional 510(k) # that also applies to this complaint: k133317.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 using a penumbra system jet d kit, the hospital staff noticed the penumbra system jet d reperfusion catheter (jet d) to be kinked upon removal from the packaging.The damage to the jet d was found prior to use, and, therefore, it was not used in the procedure.The procedure was completed using another jet d.
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