MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	GLM915030
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2026
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.Section h3 - the device is available to be returned for evaluation and testing.However, it has not been received to date.If the device returns, a device investigation will be performed.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
It was reported, via a healthcare professional, that a galaxy g3 mini 2mm x 3cm (glm920030/ 1832511s), galaxy g3 mini 2mm x 6cm (glm920060/ 1832524s), and a galaxy g3 mini 1.5mm x 3cm (glm915030/ 1612501s) were used for an endovascular embolization procedure.During the procedure, the user reported zipping difficulty & impeded in microcatheter.The event was reported as such, ¿zipping difficulty & impeded in microcatheter.It was reported that during procedure, coil microcatheter was in place, then delivered coil.During process of delivering the coil, coil microcatheter (other brand) migrated out of the aneurysm.The doctor only retracted the coil alone for adjustment, but the coil could not be retracted to the introducer sheath.The doctor removed the coil and switched a second coil, the second coil was impeded in the proximal end of the coil microcatheter and could not advance any more.The doctor only retracted the second coil alone, but it also could not be retracted to the introducer sheath.The doctor removed the second coil and coil microcatheter, then switched a second coil microcatheter (other brand) to deliver a third coil.The third coil was packed and detached in the target location.The doctor delivered the fourth coil, but it was impeded in the proximal end of the second coil microcatheter and could not advance any more.The doctor removed the second coil microcatheter and the fourth coil from patient.The doctor gave up implanting another coil.After releasing the stent, procedure was completed.The surgery was prolonged about 15 minutes.¿ no patient harm was reported.Additional event information received on 28-apr-2026 indicated that there was no allegation of patient injury due to an alleged product issue.The microcatheter was from a competitor¿s brand.Other devices were successfully used with the microcatheter prior to or after the encountered resistance.The target vessel was the c6 segment of the internal carotid artery.The c4 segment of the internal carotid artery was more tortuous.The device did not appear damaged at any time.There was a continuous flush maintained.The tip of the introducer was firmly installed into the hub of the microcatheter and locked with the rhv during device advancement.

• 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: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 25158944
• Report Number: 3008114965-2026-00682
• Device Sequence Number: 18470367
• Product Code: KRD
• UDI-Device Identifier: 10886704080145
• UDI-Public: (01)10886704080145(17)280531(10)1612501S
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K171862
• 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,Followup
• Report Date (Section B): 05/28/2026

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: GLM915030
• Device Lot Number: 1612501S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2026
• Supplement Date Received by Manufacturer: 05/21/2026
• Initial Report FDA Received Date: 05/13/2026
• Supplement Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2025
• 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