(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant medical products: guide wire: terumo stiff 0.35 (x2), sheath: cook flexor 6f 55cm.The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.
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(b)(4).Evaluation summary: (b)(4).The device was returned for evaluation and the reported resistance was unable to be confirmed.Based on visual, dimensional, and functional analysis of the returned device, there is no indication of a product quality issue with respect to manufacture, design, or labeling.A conclusive cause for the reported resistance could not be determined.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents from this lot.Based on the reviewed information, there is no indication the issue was caused by, or related to the design, manufacture or labeling of the device.
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