(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The device was not returned for analysis.It is likely that the challenging anatomical conditions resulted in the user inflating the balloon over the rbp in the attempt to open the vessel.As result, the rupture occurred resulting in a portion of the balloon to separate.It should be noted that the armada 35 instruction for use, states: inflation in excess of the rated burst pressure may cause the balloon to rupture.The lot history record (lhr) for this product could not be reviewed and a similar incident query could not be performed because the product was not returned for evaluation and the lot number was not reported.The investigation determined that the reported difficulties and additional treatment to remove the balloon fragment appear to be due to case circumstances.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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