(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Date of event - estimate.Implant date - estimate.The device was not returned for evaluation.However, factors that may contribute to difficulty deflating the balloon include, but are not limited to, deflation technique, contrast concentration, tortuous anatomy, loose connection with the indeflator, contamination in the inflation lumen or damage to the guide wire and/or inflation lumen.A review of the lot history record and complaint history of the reported device could not be conducted because the part and lot numbers were not provided.The investigation was unable to determine a conclusive cause for the reported difficulties.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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