MAUDE Adverse Event Report: MICROVENTION, INC. 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	06/26/2023
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 returned.The alleged product issue 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 preparation, a foreign substance was noticed at the tip of the scepter balloon.The device was not used on the patient.
Event or Problem Description
See h10.
Additional Manufacturer Narrative
Additional information: d10, g4, g7, h2, h3, h6 (summary device evaluation ).Summary device evaluation: the investigation of the returned balloon catheter found a kink at 62cm from the strain relief and the polyimide ring dislodged within the distal end of the balloon, 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.No additional damage to the balloon was found during functional testing.

• Brand Name: SCEPTER XC
• Common Device Name: ACCESS DEVICES
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92565
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 17313393
• Report Number: 2032493-2023-00844
• Device Sequence Number: 17161264
• Product Code: MJN
• UDI-Device Identifier: 00842429103418
• UDI-Public: (01)00842429103418(11)230404(17)260331(10)0000344716
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2023

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: 03/31/2026
• Device Model Number: BC0411XC-ID-700
• Device Catalogue Number: BC0411XC
• Device Lot Number: 0000344716
• 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: 06/26/2023
• Supplement Date Received by Manufacturer: 08/07/2023
• Initial Report FDA Received Date: 07/12/2023
• Supplement Report FDA Received Date: 08/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2023
• 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