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

Model Number	BC0415C-ID-700
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: patient undergoing angiographic aneurysm embolization.During the procedure, the catheter balloon was found to be malformed when fully inflated.The balloon was therefore unusable.They used a second scepter with success.No consequences for the patient.
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 has been returned to the manufacturer for evaluation.The investigation is ongoing.Upon completion of the investigation, a supplemental mdr will be submitted.
Additional Manufacturer Narrative
The investigation of the returned balloon microcatheter found the balloon coating damaged, causing the device to initially inflate unevenly during functional testing, which is consistent with the alleged product issue.However, the balloon eventually inflated with normal shape during the investigation.The physical evaluation of the device could not identify the conditions or circumstances that led to the coating damage, but the damage is consistent with insufficient hydration before inflation or with the balloon being set down after hydration.
Event or Problem Description
No additional information received regarding the event.

• 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: 21903802
• Report Number: 2032493-2025-90106
• Device Sequence Number: 8728751
• Product Code: MJN
• UDI-Device Identifier: 00842429117552
• UDI-Public: (01)00842429117552(11)240716(17)270630(10)0000648312
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 07/23/2025

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: BC0415C-ID-700
• Device Lot Number: 0000648312
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2025
• 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: 04/08/2025
• Supplement Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 04/24/2025
• Supplement Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2024
• 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: 78 YR
• Patient Sex: Female