MAUDE Adverse Event Report: MICROVENTION, INC. SCEPTER XC; OCCLUSION BALLOON CATHETER

Model Number	BC0411XC-ID-700
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2024
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 returned to the manufacturer for evaluation, and the investigation is ongoing.Upon completion of the investigation, a supplemental mdr will be submitted.
Event or Problem Description
It was reported that the balloon had been under water prepped by the physician and appeared to prep normally with a 10ml syringe attached to a 3 way tap and was partially inflated during this process without incident.The balloon was tracked inside the deployed flow diverter and attempted to be inflated.The haptic feedback from the 1ml inflation syringe during attempted inflation felt unusual to the physician and so screening was performed at which point it was noted that although there was no apparent contrast in the balloon it had appeared to be inflated with air.The team also suspected that some air bubbles escaped the balloon into the cerebral circulation.Whilst the haptics of balloon inflation felt slightly different there was no sudden pressure loss.The balloon was not readily visible on initial inflation with fluoro and a check was made to ensure the scrub nurse had used a saline / contrast mix in the 1ml syringe, which was confirmed.The scepter catheter did appear to centralize in the vessel on inflation indicating that it was inflating.The balloon was then deflated, and a second inflation attempt performed along with a dsa run to attempt to visualize the balloon better.At this point it appeared that the balloon may have contained air and that a few filling defects (assumed to be air bubbles) could be seen in the vessels distal to the balloon.The patient was reported to be doing well and that there appeared to be no effect to the patient post procedure as a result.
Additional Manufacturer Narrative
Investigation conclusion: the investigation of the returned balloon catheter found a flattened section at 126cm from the strain relief.The device was also returned with residual contrast within the balloon, indicating that the balloon was inflated during the procedure.After bypassing the flattened section of the device, the balloon was able to be inflated with saline, but air bubbles were observed in the balloon during functional testing.However, it is difficult to fully purge the balloon of air once it has already been inflated.Once liquid gets in the purge hole, if there¿s a bubble, it floats and gets trapped against the balloon membrane and can¿t get out again.As there was evidence of balloon inflation upon receipt, this investigation could not verify if the device inflated with air at the time of the reported event.The investigation of the returned device did not find any leaks or ruptures during balloon inflation that would have caused or contributed to the alleged air leak.As no procedure imaging was provided for review, this investigation could not assess the visibility issue under fluoroscopy described in the reported event.The physical evaluation of the device could not identify the conditions or circumstances that led to the flattened section, but this damage is consistent with the device experiencing forces over specification.
Event or Problem Description
Please see section h11 for device investigation.

• Brand Name: SCEPTER XC
• Common Device Name: OCCLUSION BALLOON CATHETER
• 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: 19111616
• Report Number: 2032493-2024-00299
• Device Sequence Number: 12537680
• Product Code: MJN
• UDI-Device Identifier: 00842429103418
• UDI-Public: (01)00842429103418(11)231024(17)260930(10)0000447109
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2024

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: 09/30/2026
• Device Model Number: BC0411XC-ID-700
• Device Lot Number: 0000447109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2024
• 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: 03/21/2024
• Supplement Date Received by Manufacturer: 06/06/2024
• Initial Report FDA Received Date: 04/15/2024
• Supplement Report FDA Received Date: 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2023
• 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