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

Model Number	BC0210M-US
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ruptured Aneurysm (4436)
Date of Event	10/17/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A search for non-conformance's 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 discarded by the user facility and not available for return to the manufacturer for analysis; therefore, a product analysis could not be conducted, and the reported issue cannot be confirmed.
Event or Problem Description
It was reported that the patient was being treated for a small arteriovenous malformation (avm) in the right hemisphere off the middle cerebral artery (mca).The physician selected the appropriate pedicle feeding artery into the avm from the right mca branch, inflated the scepter mini, and proceeded to onyx the pedicle and avm.The onyx was filling around the balloon immediately and was indicating extravasation outside of the blood vessel.After an angioma run, the pedicle vessel was shown to be ruptured.The scepter balloon was removed and after a few more angioma runs, the bleeding vessel occluded along with the avm.The indication from the physician was the patient appeared to be ok when waking up.

• Brand Name: SCEPTER MINI
• Common Device Name: SCEPTER MINI OCCLUSION BALLOON CATHETER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 15729080
• Report Number: 2032493-2022-00507
• Device Sequence Number: 12559182
• Product Code: DQY
• UDI-Device Identifier: 00842429106563
• UDI-Public: (01)00842429106563(11)220317(17)250228(10)0000164807
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K182829
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/17/2022

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: Health Professional
• Device Expiration Date: 02/28/2025
• Device Model Number: BC0210M-US
• Device Catalogue Number: BC0210M
• Device Lot Number: 0000164807
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2022
• Initial Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2022
• 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: Required Intervention
• Patient Age: 20 YR
• Patient Sex: Male