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

Model Number	BC0420C-ID-700-AL
Medical Device Problem Codes	Material Rupture (1546); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2025
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 returned to the manufacturer for evaluation.The investigation is ongoing.Upon completion of the investigation, a supplemental mdr will be submitted.
Event or Problem Description
It was report that the balloon was prepared outside of the patient successfully.When attempting aneurysm coil remodeling at carotid/ophthalmic, it only inflated proximally rather than across the whole length of the balloon.The balloon shaping was irregular when inflated for the third time at the level of the aneurysm neck, and it then burst.The patient was treated with another balloon with no issues, and the coiling was completed.There was no patient injury reported.The patient was discharged from the hospital.
Additional Manufacturer Narrative
The investigation of the returned balloon catheter found the balloon to have a pinhole leak at the distal end during inflation testing, which is consistent with the "burst" described in the reported event.However, due to the leak, the balloon could not be fully inflated during the investigation to determine if a shape irregularity was present on the balloon.The physical evaluation of the device could not identify the conditions or circumstances that led to the pinhole leak, but the damage is consistent with the device experiencing forces over specification due to over inflation.
Event or Problem Description
See h11.

• 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: 21613842
• Report Number: 2032493-2025-00225
• Device Sequence Number: 12650851
• Product Code: MJN
• UDI-Device Identifier: 00842429117569
• UDI-Public: (01)00842429117569(11)240216(17)270131(10)0000525866
• 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): 04/14/2025

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: BC0420C-ID-700-AL
• Device Lot Number: 0000525866
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2025
• 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: 02/24/2025
• Supplement Date Received by Manufacturer: 04/07/2025
• Initial Report FDA Received Date: 03/15/2025
• Supplement Report FDA Received Date: 04/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2024
• 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 Sex: Unknown