Estimated date of event.The device was not returned for analysis.The reported rupture, and difficult to remove could not be confirmed.The lot history record (lhr) for this product could not be reviewed and a similar complaint query could not be performed because the product was not returned for evaluation and the part and lot numbers were not reported.The investigation could not determine the cause for the reported rupture and difficult to remove.It may be possible that the balloon was damaged during insertion, or due to interaction with lesion calcification or associated devices causing the balloon to rupture during inflation resulting in difficulty removing from the guide wire; however, this could not be confirmed.The additional treatment was 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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