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

Catalog Number	GLX120306
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The healthcare professional reported that during an endovascular embolization procedure, the 3mm x 6cm galaxy g3 xsft (glx120306 / 0842515s) filled the target aneurysm, and the physician attempted to detach the coil, but the coil was unable to detach.The physician retracted only the coil and replaced it with another coil of a different brand to complete the procedure using the same original microcatheter (unspecified brand).There was no report of any negative patient impact.On 18-nov-2025, additional information was received.The information indicated that the coil was successfully removed from the patient; it was stretched when it was removed, but it was still attached to the delivery system.A pre-deployment electrical check was performed.The fault light was not seen during the procedure.Upon pressing the power button, the detachment light did not illuminate, and the audible signal beep was not heard.All connections fit without the application of excessive force.The information confirmed there was no negative impact on the patient and no clinically significant delay in the procedure.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (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.Section h.3: 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.A review of manufacturing documentation associated with this lot (0842515s) 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.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.
Additional Manufacturer Narrative
Manufacturer¿s ref.(b)(4).The purpose of this mdr submission is to report that the product analysis lab received the complaint device on 15-dec-2025.A supplemental 3500a report will be submitted once the product investigation has been completed.Updated sections: b.4, d.9, g.3, g.6.H.2, h.3, h.6, and h.11.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.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigational finding of the returned device.The complaint product was returned and received for evaluation and analysis.The investigation is documented below.Investigation summary: a non-sterile the 3mm x 6cm galaxy g3 xsft was received contained in the decontamination pouch.Visual inspection was performed.No damages were noted.Microscopic inspect was performed.Under magnification, the embolic coil was still attached to the resistance heating (rh) coil.The distal outer sheath had not been softened, an indication that the detachment process had not been initiated.Multiple kinks were observed on the embolic coil.The electrical resistance of the galaxy g3 device was measured with a multimeter.It measured 52.9 ohms (o), which is within the specification range between 48.5 o to 56.0 o.The device was then connected to a lab sample detachment control box (dcb), and a lab sample enpower control cable.The power was turned on.The system ready light was illuminated.Then, the detach button was pressed, and a beep sound was heard.The coil was successfully detached from the unit.The issue reported regarding the coil being stretched was confirmed based on the severe kinked condition of the embolic coil, however, the reported issue related to the coil having failure to detach cannot be confirmed since the device met the electrical specification range and the coil was successfully detached.There may have been other circumstances or issues that occurred during the use of the device that could not be replicated in the lab setting.According to the risk documentation, failure to detach is a potential issue that can occur during the coil detachment due to a detachment cycle not being initiated, as a result of the device positioning unite (dpu) wire detachment zone / extended coil being positioned beyond the microcatheter tip, which can result in reported failure.A review of manufacturing documentation associated with this lot (0842515s) 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.As part of johnson & johnson medtech quality process, all devices are manufactured, inspected, and released to approved specifications.Based on the manufacturing documentation review, 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 for statistical signals and corrective / preventive action may be triggered at a later time.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.Updated sections: b.4, g.3, g.6.H.2, h.3, h.6, and h.11.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.

• 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 ; 949788-2078
• MDR Report Key: 23607617
• Report Number: 3008114965-2025-01245
• Device Sequence Number: 13076305
• Product Code: KRD
• UDI-Device Identifier: 10886704077695
• UDI-Public: (01)10886704077695(17)280331(10)0842515S
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K150319
• 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,Followup
• Report Date (Section B): 12/16/2025

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: GLX120306
• Device Lot Number: 0842515S
• 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: 11/10/2025
• Supplement Date Received by Manufacturer: 12/15/2025; 12/16/2025
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 12/15/2025; 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2025
• 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