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

Model Number	BC0411XC-ID
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage, Cerebral (1889); Perforation of Vessels (2135)
Date of Event	01/31/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number was provided.A review of the approved device history records indicated the lot met all release criteria.A lot history trending review was performed and there were no similar complaints for this lot number.The device was not returned for evaluation; therefore, a product analysis could not be performed.The root cause cannot be determined.The ifu identifies vessel perforation and hemorrhage as potential complications associated with use of the device.
Event or Problem Description
It was reported that the scepter balloon was inflated a first time without any issue and good visibility; however, visibility of the balloon was lost during the 2nd inflation, so control of the pressure was done with a syringe.During this inflation, a rupture of the artery occurred, resulting in an intracerebral hemorrhage.The physician did not observe a device malfunction and does not know the reason for the artery rupture.The patient's outcome after the procedure was reported to be poor.The patient's current status is unknown.

• Brand Name: SCEPTER XC OCCLUSION BALLOON (4X11 MM)
• Common Device Name: BALLOON CATHETER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 7310960
• Report Number: 2032493-2018-00040
• Device Sequence Number: 11324889
• Product Code: MJN
• UDI-Device Identifier: 00842636020591
• UDI-Public: (01)00842636020591(11)170919(17)200831(10)17091953G
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K110741
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/01/2018

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: 08/31/2020
• Device Model Number: BC0411XC-ID
• Device Lot Number: 17091953G
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/01/2018
• Initial Report FDA Received Date: 03/02/2018
• 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: Required Intervention
• Patient Age: 46 YR