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

Model Number	BC0411XC-ID-700-AL
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2024
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 evaluation but has not yet been received.The alleged product issue of foreign material found on the device and incident 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 intervention, physician prepared under ifu, was inflating the balloon, noticed that there was a small orange object in the balloon.The physician then opened another balloon to continue with the case.The procedure was successful and no reported injury to the patient.
Additional Manufacturer Narrative
Based on our investigation findings that the yellow polyimide ring was dislodged within the balloon, which is consistent with the alleged product issue.The polyimide ring is a component of the device and not a foreign object as described in the reported event.Therefore, mvi no longer considers this event a reportable malfunction event.
Event or Problem Description
See h10.

• Brand Name: SCEPTER XC
• 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: 20559527
• Report Number: 2032493-2024-00783
• Device Sequence Number: 19608627
• Product Code: MJN
• UDI-Device Identifier: 00842429117583
• UDI-Public: (01)00842429117583(11)240426(17)270331(10)0000582337
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K110741
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2024

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: BC0411XC-ID-700-AL
• Device Lot Number: 0000582337
• Was Device Available for Evaluation?: No
• 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: 10/07/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/26/2024
• 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