(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The product was not returned to abbott vascular for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no similar incidents reported from this lot.The investigation was unable to determine a conclusive cause for the reported difficulty.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 procedure was performed to treat a heavily calcified lesion in the right coronary artery (rca).The 4.5 x 12 mm nc trek balloon catheter winged out after inflation to 12 atmospheres 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 to the physician, there was no clinically significant delay in the procedure.No additional information was provided.
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