(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for evaluation.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 reported from this lot.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.
|
It was reported that after unpackaging and prepping a 5.0mm x 60mm x 80cm armada 35 balloon dilatation catheter (bdc) without issue, the bdc was advanced via right brachial access to a non-calcified, non-tortuous arterio-venous (av) fistula without resistance.The armada 35 was inflated without difficulty, but inflation reportedly felt unusual.Dilatation was completed without difficulty, however, the balloon was unable to be deflated at all and was consequently difficult to remove from the av fistula.Force was applied to retract and wedge the inflated balloon into the guiding catheter then all devices were withdrawn from the anatomy as a single unit.There were no adverse patient effects and no occurrence of a clinically significant delay.No additional information was provided.
|