MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ORBIT GALAXY; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	640CF0510
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Section d2b ¿ procode: krd/hcg.(b)(6).An analysis of the product could not be performed since a physical sample was not received for evaluation.A manufacturing record evaluation was performed for the finished device 31211764 number, and no internal actions related to the malfunction were identified.Failure to detach is a known potential complication, that could cause stretching, separation and/or premature detachment.There are clinical and procedural factors, including aneurysm/vessel characteristics (i.E., tortuous anatomy), device selection, device interaction, and operator technique, that may have contributed to the reported event rather than the design or manufacture of the device.The instructions for use (ifu) contain several precautions related to this issue and includes instructions for troubleshooting the situation should it be encountered during use.With the information available and without the product available for analysis, the reported customer complaint could not be confirmed.Based on the manufacturing record evaluation, there is no indication that the event is related to the device manufacturing process.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by cerenovus, or its employees that the report constitutes an admission that the product, cerenovus, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
A healthcare professional reported that during an endovascular embolization, a competitive microcatheter (mc) was in place an orbit galaxy coil (product code: 640cf0505, lot number: 31204208) was delivered to target site.The coil was packed in the aneurysm and tried to detach, but the coil was unable to detach.The doctor only retracted the coil alone and switched to a second coil, another orbit galaxy (product code: 640cf0510, lot number: 31211764) and tried to detach it, but the second coil was also unable to detach.The doctor only retracted the second coil alone and switched to a third coil to complete the surgery.The microcatheter was not replaced.There was no patient injury reported.Additional event information received on 24-jun-2026 indicated that a pre-deployment electrical testing was not performed.The same dcb and control cables were not used with the subsequent coils.The coils were attached to the coil delivery systems when removed from the patient.The coils were not stretched or damaged when removed from the patient.There was no procedure prolongation/delay due to the event.

• Brand Name: ORBIT GALAXY
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CERENOVUS INC. (JUAREZ); circuito interior norte #1820; parque industrial salvarcar; juarez chihuahua 32574 ; MX 32574
• Manufacturer Contact: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 25623086
• Report Number: 3008114965-2026-00897
• Device Sequence Number: 8983836
• Product Code: HCG
• UDI-Device Identifier: 10886704030294
• UDI-Public: (01)10886704030294(17)251031(10)31211764
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K093973
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/25/2026

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: 10/31/2025
• Device Catalogue Number: 640CF0510
• Device Lot Number: 31211764
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2026
• Initial Report FDA Received Date: 06/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2023
• 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