(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned 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 from this lot.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.The investigation was unable to determine a conclusive cause for the reported difficulties.The 4.0 x 20 mm x 135 cm viatrac plus referenced is being filed under a separate medwatch report.
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It was reported the procedure was to treat a lesion in the common carotid artery.During preparation of the 5.0 x 20 mm x 135 cm viatrac plus balloon catheter, when pulling negative during preparation, there was air coming into the syringe due to a hole that was noted on the shaft; therefore, the device was not used.The 4.0 x 20 mm x 135 cm viatrac plus balloon catheter was not able to hold negative pressure, there was air coming into the syringe; therefore, the device was not used.The 4.0 x 30 mm x 135 cm viatrac plus had some difficulty pulling negative, but was able to be prepped.The device was advanced to the target lesion, the balloon inflated and deflated successfully.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.
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