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

Model Number	BC0210M
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/31/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: witnessed a device malfunction of the scepter mini catheter breaking off the tip during an avm treatment.The tip was left in the subject, parked in the ima at the point of embolization.The subject had no additional complication known and was stable following the procedure.The event was not a clinical case.There was manipulation of the tip to get it parked in the ima.They attempted to snare it using a 4mm and 8mm snare when the tip was in the cca, but it was not big enough and eventually migrated up the eca.From there dr.Decided it was no risk to park the tip in the ima at the point of embolization of the malformation given the tip would not be able to migrate beyond that point.
Additional Manufacturer Narrative
The lot number was not provided; therefore, a search for production-related non-conformances could not be performed.The physical device was not available for evaluation to investigate if a condition existed that would have contributed to the reported event.Supplemental imaging was also unavailable for review; without imaging, the investigation cannot verify the event occurred as described, nor could the investigation further examine the cause of the reported event.This information may be updated if additional information is provided at a later date.

• Brand Name: SCEPTER MINI
• Common Device Name: CATHETER, PERCUTANEOUS
• 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: 24841886
• Report Number: 2032493-2026-00236
• Device Sequence Number: 9827872
• Product Code: DQY
• UDI-Device Identifier: 00842429106563
• UDI-Public: (01)00842429106563
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 04/09/2026

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 Model Number: BC0210M
• Device Lot Number: UNKNOWN
• 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: 03/31/2026
• Initial Report FDA Received Date: 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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