BOSTON SCIENTIFIC - CORK CONTOUR PVA MICROSPHERES; AGENTS, EMBOLIC, FOR TREATMENT OF UTERINE FIBROIDS
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Model Number UNK90 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Pain (1994)
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Event Type
Injury
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Event Description
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Same journal article as mdr id: 2134265-2014-04844, 2134265-2014-04845, 2134265-2014-04847, 2134265-2014-04848, 2134265-2014-04849, 2134265-2014-04850 and 2134265-2014-04846 reported via journal article.It was reported that post a transcatheter arterial embolization procedure, pelvic pain occurred.After the patient had a normal spontaneous vaginal delivery (nsvd), unilateral femoral artery catheterization was performed and pelvic angiography revealed hyperaemia.The patient received contour polyvinyl alcohol particles in both uterine arteries, both ovarian arteries and both round ligament arteries.An unspecified amount of time later, the patient experienced pelvic pain.
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Manufacturer Narrative
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Hwang, s.M., jeon, g.S., kim, s.H., lee, j.T., kim, m.D., choi, m.J.(2013).Transcatheter arterial embolization for the management of obstetric haemorrhage associated with placental abnormality in 40 cases.European society of radiology, 23:766-773.Device evaluated by manufacturer: it is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
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