MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK CONTOUR PVA MICROSPHERES; AGENTS, EMBOLIC, FOR TREATMENT OF UTERINE FIBROIDS

Model Number UNK90

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Blood Loss (2597)

Event Type  Injury  

Event Description

Same journal article as mdr id: 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, hysterectomy was performed.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.An unspecified amount of time later, a hysterectomy was performed.

Manufacturer Narrative

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).

• Brand Name: CONTOUR PVA MICROSPHERES
• Type of Device: AGENTS, EMBOLIC, FOR TREATMENT OF UTERINE FIBROIDS
• Manufacturer (Section D): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer (Section G): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer Contact: ingrid matte ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4024748
• MDR Text Key: 4806543
• Report Number: 2134265-2014-04844
• Device Sequence Number: 1
• Product Code: NAJ
• Combination Product (y/n): N
• Reporter Country Code: KR
• PMA/PMN Number: K030966
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK90
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 31 YR