MAUDE Adverse Event Report: MICROVENTION, INC. SCEPTER XC OCCLUSION BALLOON (4X11 MM); OCCLUSION BALLOON CATHETER

Model Number	BC0411XC-ID
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Hemorrhage, Cerebral (1889); Rupture (2208)
Date of Event	06/25/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
The lot number was provided.A search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device was not returned to the manufacturer for analysis.The root cause cannot be determined.The instructions for use (ifu) identifies vessel or aneurysm perforation, intracerebral haemorrhage/intracranial hemorrhage.Vessel dissection, and death as potential complications associated with use of the device.
Event or Problem Description
It was reported that balloon-assisted coil embolization was attempted for an internal carotid artery (ica) aneurysm.Upon inflation of the balloon after placement at the treatment site, fluoroscopic imaging demonstrated the balloon protruding outside the ica.Extravasation was observed.Tamponade could not be completely achieved with the balloon; therefore, two flow diverters were implanted, which stopped the bleeding, and an external ventricular drain was placed.The patient died four (4) days after the procedure.The information available indicates the event was a rare, but well recognized complication associated with this type of procedure.

• Brand Name: SCEPTER XC OCCLUSION BALLOON (4X11 MM)
• Common Device Name: OCCLUSION BALLOON CATHETER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo, ca
• MDR Report Key: 10324005
• Report Number: 2032493-2020-00184
• Device Sequence Number: 14181039
• Product Code: MJN
• UDI-Device Identifier: 00842636020591
• UDI-Public: (01)00842636020591(11)191128(17)221031(10)19112852V
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K121785
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Expiration Date: 10/31/2022
• Device Model Number: BC0411XC-ID
• Device Catalogue Number: BC0411XC
• Device Lot Number: 19112852V
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2020
• Initial Report FDA Received Date: 07/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Life Threatening; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 70