(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.(b)(4).
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(b)(4).Evaluation summary: visual inspection was performed on the returned device.The reported rupture and kink were confirmed.The investigation was unable to determine a conclusive cause for the reported difficulties.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 similar incidents from this lot.It should be noted coronary dilatation catheters (cdc), trek rx and mini trek rx, global, instructions for use states: submerge the balloon in sterile heparinized normal saline during balloon preparation, to activate the coating.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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