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	Death (1802); Hemorrhage/Blood Loss/Bleeding (1888); Rupture (2208); Vascular Dissection (3160)
Date of Event	06/21/2017
Type of Reportable Event	Death
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.There was no reported device malfunction.The root cause for the event cannot be determined.The instructions for use identifies vessel dissection and death as potential complications associated with use of the device.
Event or Problem Description
It was reported that treatment was performed for an aneurysm with a 3mm neck near the a1-a2 junction.The scepter xc balloon was prepped successfully without issues.After deployment of the first coil, the balloon was positioned on the a1-a2 junction opposite the neck of the aneurysm.During the first inflation, the balloon was not visible, so the balloon was deflated and the syringe was exchanged for the same syringe with a 50% contrast/50% saline mixture used for preparation.The balloon was then re-inflated and was visible.A second coil was deployed and the balloon was deflated under fluoroscopy.A rupture of the artery and dissection in the vessel was then identified at the site of the balloon inflation.The balloon was repositioned downstream of the rupture to prevent bleeding.The patient remained hemodynamically stable for a few minutes before the vitals signs dropped.The patient was closely monitored by the anesthetist team over "several tens of minutes" and the hemorrhage was reported to have stopped.An mri was performed to evaluate the consequences of the incident.The day after the procedure, the patient died.

• 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: 6903172
• Report Number: 2032493-2017-00239
• Device Sequence Number: 1324212
• Product Code: MJN
• UDI-Device Identifier: 00842636020591
• UDI-Public: (01)00842636020591(11)170227(17)200131(10)170227ZC1
• 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): 08/29/2017

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?: Yes
• Operator of Device: Other
• Device Expiration Date: 01/31/2020
• Device Model Number: BC0411XC-ID
• Device Lot Number: 170227ZC1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/29/2017
• Initial Report FDA Received Date: 09/28/2017
• 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