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

Catalog Number	640CX0410
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.(b)(4).Information regarding patient identifier, date of birth, age, sex, gender, weight, race, and ethnicity were not provided.Section d.2b: procode is krd/hcg.Section e.1: the initial reporter phone is not available / reported.Based on complaint information, the device is not available to be returned for analysis.A review of manufacturing documentation associated with this lot (31567754) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no internal actions related to device manufacture or inspection.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.With the limited information available and without the product available for analysis, the reported issue documented in the complaint could not be confirmed.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.The exact cause of the event could not be conclusively determined; however, it is possible that circumstances of the procedure and / or device manipulation / interaction may have contributed to the reported failure.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered later.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.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
The healthcare professional reported that during a stent-assisted embolization of a right middle cerebral artery aneurysm, the microcatheter (unspecified brand) was in place and the first coil, a 2mm x 6cm orbit galaxy helical xtrasoft (640hx0206 / 31467317) was delivered to the target.The coil filled the aneurysm, and the physician tried to detach the coil, but it was unable to detach.The physician retracted only the coil and replaced it with a second coil.The second coil was placed and detached.A third coil, a 4mm x 10cm orbit galaxy complex xtrasoft (640cx0410 / 31567754) was introduced into the aneurysm, and this third coil was also unable to be detached.The physician retracted the coil and replaced it to complete the procedure using the same original concomitant microcatheter.There was no report of any negative patient impact.On 19-nov-2025, additional information was received.The information confirmed the procedure was a stent-assisted embolization of a right middle cerebral artery aneurysm.The coils were not stretched when they were removed; both coils were still attached to their respective delivery systems.There was no evidence of any blood flow restriction / interruption.The syringe was filled from a dedicated source of saline.The catalog and lot number of the syringe cannot be obtained.The same syringe was later used to successfully detach subsequent coils following the reporting of the issues with the two complaint coils.The information indicated that before attempting to deploy the coil, the syringe had not previously exceeded the green zone/position 3.Prior to the attempt to detach the coils, it was verified under fluoro that there was no stress against the microcatheter or delivery tubes.The syringe was taken to red alternative detachment zone beyond the green zone after it did not detach in the green zone.The syringe pressurized as intended.Nothing else was done in attempt to detach the coils.The information confirmed there was no negative impact on the patient and no delay in the procedure resulted from the reported issue.

• Brand Name: ORBIT GALAXY XTRASOFT
• 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 ; 949788-2078
• MDR Report Key: 23623555
• Report Number: 3008114965-2025-01289
• Device Sequence Number: 21095288
• Product Code: KRD
• UDI-Device Identifier: 10886704030645
• UDI-Public: (01)10886704030645(17)261231(10)31567754
• 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): 11/21/2025

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 Catalogue Number: 640CX0410
• Device Lot Number: 31567754
• 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: 11/13/2025
• Initial Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/31/2025
• 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: MICROCATHETER (UNSPECIFIED BRAND)
• Patient Sex: Unknown