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

Catalog Number	GLM910030
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The healthcare professional reported that during an endovascular embolization procedure, when filling the target site with coils, it was found that the coil, a 2.00mm x 6.00cm galaxy g3 mini (glm920060 / 0442502s) was unable to rotate randomly and the shape of the coil was not ideal.The physician retracted only the coil and replaced it with a second coil, a 1.50mm x 3.00cm galaxy g3 mini (glm915030 / 1502509s) and a third coil, 1.00mm x 3.00cm galaxy g3 mini (glm910030 / 1112514s) successively.The second and the third coil had the same issue as the first coil.The physician retracted the coils and eventually replaced it with a fourth coil (unspecified competitor brand) to complete the procedure using the same original microcatheter (unspecified brand).There was no report of any negative patient impact.
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: (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 (1112514s) 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.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 03-dec-2025.[additional information]: on 03-dec-2025, additional information was received.The information indicated that the procedure was targeting an unruptured aneurysm on the ophthalmic segment of the internal carotid artery (ica).The information indicated that there were no damages observed on them when they were removed.The information confirmed there was no negative patient impact and no clinically significant delay in the procedure.Updated sections: b.4, g.3, g.6, h.2, 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 that the product analysis lab received the complaint device 17-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 1.00mm x 3.00cm galaxy g3 mini was received contained in the decontamination pouch.Visual inspection was performed.It was noted that the coil is outside of the introducer.Microscopic inspection was performed on the coil.It was noted to be severely stretched.As a result of this stretching, the internal blue fiber was exposed.The coil, however, still remains attached to the resistance heating (rh) coil.No other damages were found on the device.The reported issue regarding the coil being unable to rotate randomly and that the shape of the coil was not ideal was confirmed during the microscopic inspection.Coil stretching is a known potential issue associated with the use of this device.The instruction for use (ifu) provides proper handling instructions for the device to prevent such issues from occurring.Stretching can occur during device handling where force may have been inadvertently applied in an attempt to reach the desired shape.The coil stretching was not originally documented in the complaint.With the limited information available, there is no indication that the issue reported in the complaint is a result of a defect inherently related to the device.Factors such as the aneurysm characteristics (i.E.Wide neck) may have contributed to the issue encountered.A review of manufacturing documentation associated with this lot (1112514s) 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 multiple factors could cause product failure.The instruction for use (ifu) does contain the following recommendations: the appropriate micro-coil size should be chosen based on pre-embolization angiographic assessment of the diameter, height, and width of the aneurysm, as well as the width of the aneurysm ostium (neck).Do not fasten the rhv valve too tightly around the introducer sheath since excessive pressure may cause damage to the introducer sheath and/or the microcoil as it is advanced into the infusion microcatheter.Additionally, if the introducer tip and microcatheter hub are misaligned, damage may occur to the microcoil as it passes through this transition.To obtain proper positioning of the microcoil system for detachment under fluoroscopic guidance, align the radiopaque marker on the dpu wire just past the proximal marker band on the tip of the microcatheter.Once the desired microcoil placement has been achieved, gently tighten the rhv around the dpu wire to maintain its position.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: 23661059
• Report Number: 3008114965-2025-01287
• Device Sequence Number: 18410050
• Product Code: KRD
• UDI-Device Identifier: 10886704080244
• UDI-Public: (01)10886704080244(17)280430(10)1112514S
• 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,Followup
• Report Date (Section B): 12/17/2025

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: 1112514S
• 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: 11/13/2025
• Supplement Date Received by Manufacturer: 12/03/2025; 12/17/2025; 12/17/2025
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 12/04/2025; 12/17/2025; 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2025
• 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