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

Model Number	BC0411XC-ID-700
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2023
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: during balloon preparation, the physician noticed an orange piece (foreign body) in the lumen of the balloon.There was no impact to the patient as the device had no patient contact.Although requested no additional clarification has been received as of this report date.
Event or Problem Description
No additional information has been received.
Additional Manufacturer Narrative
Investigation findings: items returned for evaluation: scepter xc.The device was returned with the yellow polyimide ring dislodged and the coils at the proximal end of the balloon were found to be unwound.This damage is consistent with the condition observed in the customer provided images.No other damage was observed.The investigation of the returned balloon catheter found the coils at the proximal end of the balloon to be unwound and the yellow polyimide ring dislodged within the balloon near the unwound coils, which is consistent with the alleged product issue.However, the polyimide ring is a component of the device and not a foreign object as described in the reported event.The physical evaluation of the device could not identify the exact conditions or circumstances that led to the polyimide ring dislodging, but this condition is consistent with the device experiencing forces over specification due to over inflation.

• Brand Name: SCEPTER XC OCCLUSION BALLOON
• Common Device Name: CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY
• Manufacturer (Section D): MICROVENTION, INC; 35 enterprise; aliso viejo CA 92656
• Manufacturer (Section G): MICROVENTION, INC; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 18499918
• Report Number: 2032493-2024-00041
• Device Sequence Number: 20869613
• Product Code: MJN
• UDI-Device Identifier: 00842429103418
• UDI-Public: (01)00842429103418(11)230504(17)260430(10)0000357692
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2024

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 Expiration Date: 04/30/2026
• Device Model Number: BC0411XC-ID-700
• Device Lot Number: 0000357692
• 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: 01/03/2024
• Supplement Date Received by Manufacturer: 03/05/2024
• Initial Report FDA Received Date: 01/11/2024
• Supplement Report FDA Received Date: 03/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown