MAUDE Adverse Event Report: MICROVENTION, INC. SCEPTER XC OCCLUSION BALLOON; BALLOON CATHETER

Model Number	BC0411XC-ID-700
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Rupture (2208); Hemorrhagic Stroke (4417)
Date of Event	11/22/2021
Type of Reportable Event	Death
Event or Problem Description
It was reported that a scepter xc balloon was used during treatment of two unruptured aneurysms of the right middle cerebral artery.The first aneurysm was treated without incident.During treatment of the second aneurysm, the anatomical configuration of the patient vessel inhibited the inflated balloon from protruding fully into the aneurysm sac.During balloon inflation, the portal artery ruptured causing a severe cerebral hemorrhage.Hemostasis was attempted by inflating the balloon in the carotid endings, but was not successful.The surgeon then attempted to stop the hemorrhage by occluding the middle cerebral artery with coils, but the patient suffered a stroke and passed away shortly thereafter.
Additional Manufacturer Narrative
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.Procedural or post procedural images were not provided; therefore, the alleged event and product issue cannot be confirmed.If the product, additional images, or information is received at a later date, the investigation will be reopened and a supplemental report will be submitted.The instructions for use (ifu) identifies vessel or aneurysm perforation, intracerebral/intracranial hemorrhage, stroke, vessel dissection, and death as potential complications associated with use of the device.
Additional Manufacturer Narrative
The device was received for investigation.However, analysis was not possible and the cause of the reported complaint could not be determined.During examination of the catheter, the balloon was inflated to look for any potential shape abnormalities.However, due to dried contrast inside of the device, pressure accumulated during inflation, the dried contrast was dislodged, and as a result, the balloon ruptured before the testing could be completed.The company attempted to obtain further information and medical imaging in order to enable the investigators to determine if there were anatomical impediments to balloon inflation, but these requests were unsuccessful.The inability to obtain information from the user concerning the conditions under which the device was used (including pressure and/or volume pushed into device) prevented investigators from determing the cause of the event.

• Brand Name: SCEPTER XC OCCLUSION BALLOON
• Common Device Name: BALLOON CATHETER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 13049228
• Report Number: 2032493-2021-00492
• Device Sequence Number: 3951210
• Product Code: MJN
• UDI-Device Identifier: 00842429103418
• UDI-Public: (01)00842429103418(11)210505(17)240430(10)21050556V
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K113698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2021

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: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: BC0411XC-ID-700
• Device Lot Number: 21050556V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2021
• Supplement Date Received by Manufacturer: 03/03/2022
• Initial Report FDA Received Date: 12/20/2021
• Supplement Report FDA Received Date: 03/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Female