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

Model Number	BC0420C-ID-700-AL
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2025
Type of Reportable Event	Malfunction
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 analysis.However, the device has not yet been returned to the manufacturer.The alleged product issue could not be confirmed.If the device is received at a later date, an investigation will be performed and a supplemental report will be submitted.
Event or Problem Description
It was reported that the physician was treating an ica aneurysm on the right.A coil embolization in remodeling technique was planned.As the balloon for remodeling a scepter c 4-20 was chosen.The balloon was prepared without any issue.During the third inflation (inside the patient), the physician noticed a sudden deflation and contrast media rinsing from the distal tip of the scepter c.The balloon was completely deflated and removed from the patient body.When the physician checked the balloon, they found a leakage.The scepter c was exchanged and the examination continued with good result.The patient is doing well.No injury caused by this issue.There was no intervention.
Additional Manufacturer Narrative
The investigation of the returned device found the balloon ruptured, which is consistent with the alleged product issue.The physical evaluation of the device could not identify the conditions or circumstances that led to the rupture, but the damage is consistent with the device experiencing inflation pressure exceeding the strength of the balloon membrane.
Event or Problem Description
It was reported that the physician was treating an ica aneurysm on the right.A coil embolization in remodeling technique was planned.As the balloon for remodeling a scepter c 4-20 was chosen.The balloon was prepared without any issue.During the third inflation (inside the patient), the physician noticed a sudden deflation and contrast media rinsing from the distal tip of the scepter c.The balloon was completely deflated and removed from the patient body.When the physician checked the balloon, they found a leakage.The scepter c was exchanged and the examination continued with good result.The patient is doing well.No injury caused by this issue.There was no intervention.

• 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: 23652914
• Report Number: 2032493-2025-90673
• Device Sequence Number: 20059452
• Product Code: MJN
• UDI-Device Identifier: 00842429117569
• UDI-Public: 00842429117569
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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
• Report Date (Section B): 02/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: BC0420C-ID-700-AL
• Device Catalogue Number: BC0420C
• Device Lot Number: 0000756063
• 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: 11/10/2025
• Supplement Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2024
• 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
• Patient Age: 46 YR
• Patient Sex: Female