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

Catalog Number	GLM910020
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	Intracranial Hemorrhage (1891)
Date of Event	01/01/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.The device was returned to j&j medtech for further evaluation.A non-sterile galaxy g3 mini 1mm x 2cm was received contained in the decontamination pouch.Upon receiving the device, visual inspection was performed, and the coil was protruding from the introducer through a slit.The coil was still attached to the gripper.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint condition were identified.The issue reported regarding the re-sheathing difficulties is confirmed based on the protruded coil.Risk documentation states that a delivery tube / embolic coil that cannot be pushed through the microcatheter is a potential issue that can occur during coil placement due to: 1) excessively tortuous anatomy; or 2) clot formation in the microcatheter.With limited information available, the root cause remains speculative, however, there is no indication that the issues encountered during the procedure are a result of a defect inherently related to the device.As part of j&j medtech quality process, all devices are manufactured, inspected, and released to approved specifications.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no internal action is proposed at this time.It should be noted that product failure is multifactorial.The instructions for use contain the following precautions and warnings: if unusual friction is still noticed during advancement or retraction of the microcoil system, verify flush lines are open and properly pressurized.Then, slowly withdraw the entire microcoil system and examine for damage.Replace it with a new microcoil system.If friction still exists, withdraw and examine the delivery catheter system.During coil retraction, verify under fluoroscopy that a one-to-one relationship exists between the delivery tube and the coil.If not, the coil has been stretched, which could lead to premature detachment or coil fracture.If the one-to-one relationship does not exist, remove the infusion catheter and the detachable coil as an assembly and replace.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.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.Rezipping difficulty is a known procedural issue associated with the galaxy g3 mini coil.There is evidence of a product malfunction, as the device failed to meet its performance specification or otherwise performed as intended, however the potential that it could cause or contribute to a death or serious injury, is remote.There are clinical and procedural factors, including vessel characteristics, device interaction, and operator technique, that may have contributed to the reported event.There was no allegation of increased bleeding or new vessel damage caused by the device malfunction.However, it was reported that the need to switch devices resulted in a clinically significant procedural delay in the context of an already perforated aneurysm with ongoing bleeding; the delay affected how quickly the physician was able to achieve hemostasis.The severity of the event is unknown.Therefore, this event will be conservatively reported to the us fda under reporting criteria 21 cfr 803 with a classification of ¿serious injury¿ with an awareness date of 25-feb-2026.The file will be re-reviewed if additional information is received at a later date.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 1mm x 2cm (glm910020/ 2102522s) was used for an endovascular embolization procedure to treat an aneurysm.During the procedure, the user reported the coil couldn¿t fit into the aneurysm (unknown reason) and the coil was resheathed, however, could not be resheathed in a way that allowed the coil to be used again later.Another coil (competitor brand) was used and the procedure was completed.On 25-feb-2026, additional event information was received.Summary: per the information provided, an excelsior sl 10 microcatheter was used (stryker).Regarding whether the event resulted a procedural delay that could be considered clinically significant, it was reported, ¿the aneurysm was perforated, so, we lost time in using another coil.¿ relevant anatomical information was reported as ¿no relevant tortuosity.¿ resulting patient consequences were reported as ¿more subarachnoidal bleeding than had to be.¿ no further information was made available at the time of this review.

• 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: 24559137
• Report Number: 3008114965-2026-00404
• Device Sequence Number: 9422081
• Product Code: KRD
• UDI-Device Identifier: 10886704080237
• UDI-Public: (01)10886704080237(17)280731(10)2102522S
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 03/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: GLM910020
• Device Lot Number: 2102522S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/25/2025
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown