MAUDE Adverse Event Report: Medos International SARL GALAXY G3; Neurovascular embolization device

Catalog Number	GLY120515
Medical Device Problem Codes	Separation Failure (2547); Component or Accessory Incompatibility (2897)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare professional reported that this was a coil embolization using a galaxy g3 5mm x 15cm coil (product code: gly120515, lot number: 2512562s).During coil detachment, connection to the main unit could not be made, so the device could not be detached and was removed.The reported product issue was failure to detach with connection incompatibility at the detachment interface.No patient consequences or clinical signs or symptoms were reported.
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Section b3 ¿ date of event: the date of the event was not reported.Section d2b¿product code: krd/hcg.Section g4-pma/ 510(k)k150319;k171747.Section h3¿device return: the device is available for evaluation and testing but has not been received.If returned, a device investigation will be performed.Missing information is identified as blank because it was not provided in the event report or available when the report was submitted.This report is submitted pursuant to 21 cfr part 803 and may be based on information that had not been investigated or verified by the required reporting date.The submission does not constitute an admission by cerenovus or its employees that the product, cerenovus, or its employees caused or contributed to the reported event.If information becomes available that was not included in the initial report, a supplemental report will be submitted as appropriate.

• Brand Name: GALAXY G3
• 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. (Fremont); 47709 fremont blvd; fremont CA 94538
• Manufacturer Contact: katie seppa ; 31 technology dr; irvine, CA 92618 ; +1(513)337-8052
• MDR Report Key: 50949613
• Report Number: 3008114965-2026-01297
• Device Sequence Number: 10451702
• Product Code: HCG
• UDI-Device Identifier: 10886704077510
• UDI-Public: (01)10886704077510(17)280831(10)2512562S
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 09/30/2026

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 Catalogue Number: GLY120515
• Device Lot Number: 2512562S
• 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: 09/18/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/17/2025
• 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
• Patient Sex: Unknown