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

Model Number	BC0411XC-ID-700-AL
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A search for non-conformances associated with the reported 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 deflation issue 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 report will be submitted.
Event or Problem Description
It was reported that: after using the balloon at the neck of the of the sylvian aneurysm to be embolized, the physician found it was impossible to deflate the balloon.The scepter was removed gently and very slowly to avoid any damage to the artery wall.The physician used another scepter to perform / complete the procedure.No actual patient impact or injury is documented, and it was confirmed patient outcome was good at the end of the procedure.No other information was provided.
Additional Manufacturer Narrative
A search for non-conformances associated with the reported part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.Investigation findings items returned for investigation: balloon microcatheter items not returned for investigation: n/a the balloon was returned deflated with the guidewire lumen kinked.The hub was intact with residual contrast.The balloon was inflated with the residual fluid in the lumen and deflated without difficulty during the investigation.Investigation conclusion the investigation of the returned balloon catheter found the guidewire lumen kinked in the balloon area; however, the balloon was able to inflate and deflate normally during the investigation.Air was observed during inflation testing; however, it is difficult to fully purge the balloon of air once it has already been inflated as indicated in the reported event.The physical evaluation of the device could not identify the conditions or circumstances that led to the guidewire lumen damage, but this damage is consistent with the device experiencing forces exceeding the guidewire lumen's yield strength.
Event or Problem Description
No other information was provided.Please see d10, h6 & h11.

• Brand Name: SCEPTER XC
• Common Device Name: CATHETER, PERCUTANEOUS
• 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: 20909099
• Report Number: 2032493-2024-00896
• Device Sequence Number: 7846357
• Product Code: DQY
• UDI-Device Identifier: 00842429117583
• UDI-Public: (01)00842429117583(11)240628(17)270531(10)0000639337
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K182829
• 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): 01/29/2025

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: 0000639337
• 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: 12/02/2024
• Supplement Date Received by Manufacturer: 01/13/2025
• Initial Report FDA Received Date: 12/11/2024
• Supplement Report FDA Received Date: 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown