MAUDE Adverse Event Report: MICROVENTION SCEPTER XC; ACCESS DEVICES

Model Number	BC0411XC-ID-700
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2024
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 returned.The complaint 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 the doctor observed debris floating in the scepter xc balloon during device preparation.This was realized during injection of contrast solution through balloon inflation port.The device was not used and was discarded, a new scepter xc was selected.The device was not used in patient; no negative outcome caused by device.
Additional Manufacturer Narrative
Investigation conclusion: 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.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.
Event or Problem Description
No additional information was received.

• Brand Name: SCEPTER XC
• Common Device Name: ACCESS DEVICES
• Manufacturer (Section D): MICROVENTION; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 19134009
• Report Number: 2032493-2024-00309
• Device Sequence Number: 11926705
• Product Code: MJN
• UDI-Device Identifier: 00842429103418
• UDI-Public: (01)00842429103418(11)231101(17)261031(10)0000452822
• 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): 06/03/2024

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
• Device Lot Number: 0000452822
• 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: 03/27/2024
• Supplement Date Received by Manufacturer: 05/15/2024
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 06/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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