MAUDE Adverse Event Report: EMBOZENE¿ MICROSPHERES; EMBOLIC DEVICE

Model Number UNK939

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

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Boston scientific acquired celonova on (b)(4) 2015.As part of the acquisition, a retrospective review of post-market complaints was completed by bsc on (b)(4) 2016.This specific event was not previously identified by celonova as meeting reporting criteria.When evaluated by bsc, it was assessed as meeting reporting criteria and is being reported within 30 days of the (b)(4) 2016 review.(b)(4).Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.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).

Event Description

It was reported that the patient required a re-embolization.The patient underwent an embolization procedure of the bronchial artery using embozene microspheres.Within 48 hours of the procedure, the patient was required to undergo a re-embolization as re-bleeding was noted.The patient was noted to have multiple bronchial arteries and collaterals.The patient was reported to have done well.

• Brand Name: EMBOZENE¿ MICROSPHERES
• Type of Device: EMBOLIC DEVICE
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6014120
• MDR Text Key: 56919775
• Report Number: 2134265-2016-09556
• Device Sequence Number: 1
• Product Code: NAJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK939
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2016
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention