(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Date of event estimated udi# in the absence of a reported part number, the udi cannot be calculated.The product was not returned to abbott vascular for analysis.The investigation was unable to determine a conclusive cause for the reported difficulty.A review of the lot history record and complaint handling database was not performed since the part and lot numbers were not provided.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
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It was reported that the nc trek balloon catheter winged out after inflation and could not be pulled back into the guiding catheter.Both devices had to be removed as a single unit.There was no adverse patient effect.Although, this caused an inconvenience, there was no clinically significant delay in the procedure.No additional information was provided.
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