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In Riegel, plaintiff brought suit in a New York federal court alleging state-law claims regarding the design, manufacture, and sale of the catheter.  A catheter, marketed by Medtronic, was used during the plaintiff's coronary angioplasty surgery.  The device was used during the plaintiff's surgery even though the device's labeling and instructions for use said that it should not be used with patients suffering from diffuse or calcified stenoses like the plaintiff was. The plaintiff had suffered a myocardial infarction. The catheter ruptured.