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

Model Number	BC0420C-ID-700
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
Type of Reportable Event	Serious Injury
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 analysis and the investigation ongoing.Upon completion of the investigation, a supplemental mdr report will be submitted.
Event or Problem Description
It was reported that a scepter c balloon 4 x 20 could not be deflated during a balloon assisted coiling of ruptured large (l) superior hypophysial artery aneurysm procedure.Difficult access.Had to loop the catheter in the aneurysm to get the outflow.Inflated the balloon in mca to get rid of the loop.Balloon stayed inflated despite using 60 cc syringe.Could have kinked the catheter with that maneuver.Perhaps the guidewire should have been left it in the catheter.Balloon was prep the usual way and deflated normally prior to insertion.Additionally reported: looped balloon inside aneurysm to find outflow and inflated in mca and straightened out loop.Balloon inflated but would not deflate.Balloon inflated and deflated well on testing in petrous ica.But after getting distal to aneurysm (tortuous anatomy) balloon inflated but would not deflate.The case was completed with coils.The patient was reported to be doing good.No harm done on patient.The patient is clinically well.
Additional Manufacturer Narrative
Corrections were made to the following: d.8 - was this device serviced by a third party servicer? and g.3.- report source(s) manufacturer narrative: additional information was received from the reporter and are described in b.5.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 analysis and the investigation ongoing.Upon completion of the investigation, a supplemental mdr report will be submitted.
Event or Problem Description
It was reported that a scepter c balloon 4x20 could not be deflated during a balloon assisted coiling of ruptured large (l) superior hypophysial artery aneurysm procedure.Difficult access.Had to loop the catheter in the aneurysm to get the outflow.Inflated the balloon in mca to get rid of the loop.Balloon stayed inflated despite using 60 cc syringe.Could have kinked the catheter with that maneuver.Perhaps the guidewire should have been left it in the catheter.Balloon was prep the usual way and deflated normally prior to insertion.Additionally reported: looped balloon inside aneurysm to find outflow and inflated in mca and straightened out loop.Balloon inflated but would not deflate.Balloon inflated and deflated well on testing in petrous ica.But after getting distal to aneurysm (tortuous anatomy) balloon inflated but would not deflate.The case was completed with coils.The patient was reported to be doing good.No harm done on patient.The patient is clinically well.Additional information was received, and it was reported that the balloon was removed through 7f guiding catheter, and the physician coiled partially.It was reported that the case was then completed the following days by using a flow diverter.It was reported that the 7f competitor guiding catheter was already in place and was used to remove the scepter balloon catheter.It was reported that the physician had to schedule another procedure when the patient settled.The physician prepped the patient in order to flow divert.The patient was treated with a competitor's flow diverter in the following days.
Event or Problem Description
Please see section h11 for device investigation results and corrections for adverse event.
Additional Manufacturer Narrative
Corrected data: b1: report type - adverse event.H1: type of reportable event - serious injury.H6: health effect - impact code.Investigation conclusion: the investigation of the returned scepter c balloon microcatheter found the inflation lumen occluded with residual contrast, which is consistent with the contrast mixture used during the procedure drying over time.The occlusions were bypassed, and the balloon was able to inflate and deflate normally during functional testing.Air was observed to partially fill the balloon during the 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 investigation of the returned device did not find any damage or other anomaly that would have caused or contributed to the reported complaint.

• Brand Name: SCEPTER C
• Common Device Name: 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: 21914621
• Report Number: 2032493-2025-90113
• Device Sequence Number: 9390377
• Product Code: MJN
• UDI-Device Identifier: 00842429103401
• UDI-Public: (01)00842429103401(11)230317(17)260228(10)0000336606
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2026
• Device Model Number: BC0420C-ID-700
• Device Lot Number: 0000336606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2025
• 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: 04/04/2025
• Supplement Date Received by Manufacturer: 04/29/2025; 07/01/2025
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 05/25/2025; 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TRAXCESS GUIDEWIRE.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 65 KG