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

Model Number	BC0410C-ID-700-AL
Medical Device Problem Codes	Material Rupture (1546); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to the manufacturer for evaluation.The investigation is currently ongoing.A supplemental report will be submitted when the investigation is completed.The instructions for use (ifu) identifies failure to deflate as potential complications associated with use of the device.
Event or Problem Description
As reported, during a flow diversion with pipeline.The stent would not open so they angio-plastied with a scepter.After they inflated to open the stent, the scepter would not deflate.Multiple syringes were tried and would not deflate.The physician had to pull the scepter while inflated and pulled within the guide catheter making it pop to get inside.The case was completed per usual protocol.Angio-plastied the stent and removed the scepter inflated through the guide catheter.No intervention performed.The patient is asymptomatic.
Additional Manufacturer Narrative
The investigation of the returned balloon catheter found the balloon ruptured at the distal end and dislodged lumen coils under the polyimide ring.Dyed saline was injected into the inflation lumen during the investigation; however, the saline leaked out from the balloon through the rupture site and therefore, could not be inflated to then assess the balloon's ability to deflate.No flow issues were observed during the injection of the saline.The physical evaluation of the device could not identify the conditions or circumstances that led to the rupture and the dislodged lumen coils, but these conditions are 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; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 21186043
• Report Number: 2032493-2025-00070
• Device Sequence Number: 8546108
• Product Code: MJN
• UDI-Device Identifier: 00842429117545
• UDI-Public: (01)00842429117545(11)240819(17)270731(10)0000677208
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2025

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: BC0410C-ID-700-AL
• Device Lot Number: 0000677208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2025
• 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: 01/09/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/17/2025
• Supplement Report FDA Received Date: 02/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2024
• 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