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

Catalog Number	GLM910030
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2025
Type of Reportable Event	Malfunction
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: (b)(6).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 (1352512s) 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.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 an endovascular embolization procedure, the microcatheter (unspecified competitor brand) was in place and the 1.00mm x 3.00cm galaxy g3 mini (glm910030 / 1352512s) was delivered to the target site.The coil filled the aneurysm, and the physician tried to detach the coil, but it was unable to be detached.The physician retracted the coil and replaced it with a new coil to fil the aneurysm and detached.As the procedure progressed, a second coil, a 1.00mm x 1.00cm galaxy g3 mini (glm910010 / 1112512s) was placed and the same detachment issue was encountered.The physician retracted only the coil and replaced it to complete the procedure using the same original microcatheter.There was no report of any negative impact on the patient.
Additional Manufacturer Narrative
Manufacturer¿s ref.No:(b)(4).The purpose of this mdr submission is to report that the product analysis lab received the complaint device on 23-oct-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 include the additional event information received on 28-oct-2025 and to report the investigational finding of the returned device.[additional information]: on (b)(6) 2025, additional information was received.Per the information, the target vessel of the procedure was the internal carotid artery (ica).Both coils were successfully removed from the patient; the coils were still attached to their respective delivery systems and were not stretched when they were removed.A pre-deployment electrical check was performed.The fault light was not seen during the procedure.Upon pressing the power button, all lights illuminated.The green system ready light did illuminate and during the detachment cycle, the detachment light illuminated, and the audible signal beep was heard.All connections appear to fit properly 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.The complaint product was returned and received for evaluation and analysis.The investigation is documented below.Investigation summary: a non-sterile 1.00mm x 3.00cm galaxy g3 mini was received contained in the decontamination pouch.Visual inspection was performed.No appearance of damage was observed.Microscopic inspection was performed.The embolic coil was observed 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 kins were found on the embolic coil, and the proximal portion was folded.The electrical resistance of the galaxy g3 device was measured with a multimeter.It measured 54.3 ohms (o), which is within the specification range between 48.5 o ¿ 56.0 o.The device was connected to a lab sample detachment control box (dcb), and to a lab sample enpower control cable, and the power was turned on.The system ready light was illuminating.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 failure to detach the embolic coil could not be confirmed since the device met the electrical specification range.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.The instruction for use (ifu) provides proper handling instructions for the device to prevent such issues from occurring.The kinks and folded conditions of the embolic coil were not originally reported, and the exact time of occurrence cannot be determined; therefore, these are not considered related to the issue reported.A review of manufacturing documentation associated with this lot (1352512s) 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.It should be noted that product failure could be caused by multiple factors.The instruction for use (ifu) does contain the following recommendation: verify that the microcoil delivery system is fully connected, and no faults are indicated on the dcb.If a fault exists, reseat all connections between the dpu, the dcb, and the connecting cable.If a fault still persists, replace the connecting cable.If this does not correct the error, replace the dcb.If the microcoil delivery system still continues to have a fault, retrieve the microcoil, re sheathing the microcoil system, and replace it with a new microcoil system.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: 23319218
• Report Number: 3008114965-2025-01031
• Device Sequence Number: 4989343
• Product Code: KRD
• UDI-Device Identifier: 10886704080244
• UDI-Public: (01)10886704080244(17)280430(10)1352512S
• 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,Followup
• Report Date (Section B): 10/29/2025

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: GLM910030
• Device Lot Number: 1352512S
• 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: 09/28/2025
• Supplement Date Received by Manufacturer: 10/23/2025; 10/28/2025
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 10/23/2025; 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2025
• 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