MAUDE Adverse Event Report: MICROVENTION, INC. SCEPTER C; CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY

Model Number	BC0410C-ID-700
Medical Device Problem Codes	Gas/Air Leak (2946); Air/Gas in Device (4062)
Health Effect - Clinical Codes	Air Embolism (1697); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2025
Type of Reportable Event	Serious Injury
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 stated to be available for return to the manufacturer for evaluation but has not yet been returned despite a device return attempt.Ongoing attempts will be made for the device return.The alleged product issue/event as described could not be confirmed.If the device is received at a later date, an investigation will be performed and a supplemental mdr will be submitted.
Event or Problem Description
As reported: discovered air leaking from the balloon, so the device was retrieved immediately.The leak was observed inside the patient.It was a slow leak inside the patient body.The procedure was completed with another device.No additional intervention was performed.Patient is stable.
Event or Problem Description
No additional information received regarding the event description.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
The investigation of the returned balloon microcatheter found kinks at 39cm and 78cm from the strain relief.The balloon was injected with dyed saline and exhibited a pinhole leak during inflation testing, which is consistent with the leak described in the reported event; however, the investigation did not find any condition that would introduce air into the system.The physical evaluation of the device could not identify the conditions or circumstances that led to the leak, but this condition is consistent with the device experiencing inflation forces over specification.The physical evaluation of the device could not identify the conditions or circumstances that led to the kinks, but the kinks are consistent with the device experiencing forces that exceeded its yield strength.
Event or Problem Description
No additional information received regarding the event description.

• Brand Name: SCEPTER C
• Common Device Name: CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY
• 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: 21904029
• Report Number: 2032493-2025-90107
• Device Sequence Number: 12939786
• Product Code: MJN
• UDI-Device Identifier: 00842429117545
• UDI-Public: (01)00842429117545(11)240610(17)270531(10)0000622246
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K121785
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/10/2025

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 Model Number: BC0410C-ID-700
• Device Lot Number: 0000622246
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/10/2025
• Supplement Date Received by Manufacturer: 05/27/2025; 07/08/2025
• Initial Report FDA Received Date: 04/24/2025
• Supplement Report FDA Received Date: 05/29/2025; 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2024
• 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: Other
• Patient Sex: Unknown