MAUDE Adverse Event Report: MICROVENTION INC. SCEPTER XC; PERCUTANEOUS CATHETER

Model Number	BC0411XC-ID-700-AL
Medical Device Problem Codes	Failure to Deliver (2338); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2025
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.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
It was reported that during a cerebral embolization, the doctor had the complaint balloon prepared under ifu.However, upon attempting to inject onyx through the balloon, it was not able to inject any onyx at all.Embolization was aborted as the result of that.It is unknown why another device was not used to complete the case.The patient current condition was reported as left untreated.
Event or Problem Description
See h11.
Additional Manufacturer Narrative
This report is being submitted to notify of a corrections /additional information of the initial mdr.Corrections: b1 selected: adverse event.B2 selected: other serious (important medical events).H1 malfunction corrected to serious injury.H6 codes: health impact: added 4633.Clinical code: corrected from 4580 to 4582.Device code: corrected 2993 to 2338.Additional information: d10: device returned to manufacturer.The device was 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 scepter xc balloon microcatheter found a kink at 3cm from the hub tip and a flattened section at 126cm from the strain relief, which could have contributed to the difficulty injecting onyx as described in the reported event.However, solidified onyx was found in the distal end of the lumen, indicating that some injection did occur.Premature solidification is consistent with onyx coming into contact with saline, blood, or contrast inside the microcatheter.The physical evaluation of the device could not identify the conditions or circumstances that led to the kink and flattened section, but the damage is consistent with the device experiencing forces that exceeded its yield strength.

• Brand Name: SCEPTER XC
• Common Device Name: PERCUTANEOUS CATHETER
• 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: 21704294
• Report Number: 2032493-2025-90006
• Device Sequence Number: 18674753
• Product Code: DQY
• UDI-Device Identifier: 00842429117583
• UDI-Public: (01)00842429117583(11)240425(17)270331(10)0000583163
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/12/2025

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: BC0411XC-ID-700-AL
• Device Lot Number: 0000583163
• 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: 03/03/2025
• Supplement Date Received by Manufacturer: 04/10/2025; 06/05/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 04/26/2025; 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2024
• 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