During inflation, the balloon ruptured.Recurrence of this malfunction could result in a prolonged intervention.No patient injury reported.Cross reference mfr report numbers: 3009784280-2019-00753, 3009784280-2019-00755.Patient information regarding relevant tests/laboratory data or medical history are unknown.The lot number was not provided by the facility, thus the following information are unknown: unique id, dose, model #, catalog #, expiration date, and manufacture date report source: foreign (b)(6).Per fda request, this mdr is being reported retrospectively.The stellarex device was discarded by the facility, thus no returned product investigation was performed.Per the ifu, balloon rupture is listed as a potential complication of the peripheral balloon.
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