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

Catalog Number	640CF0615
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2026
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
A healthcare professional reported that during a coil embolization, a microcatheter (competitor¿s brand) was in place and an orbit galaxy coil (product code: 640cf0615, lot number: 31638655) was delivered to the target site.The coil was deployed within the aneurysm.The physician attempted to detach the coil; however, the coil did not detach.The physician retracted only the coil and replaced it with a new coil to complete the procedure.The microcatheter (mc) was not replaced.No patient injury was reported.Additional event information received on 17-mar-2026 indicated that a trufill dcs syringe was used.The same syringe was used to detach subsequent coils.The same syringe did not previously exceeded the green zone/position 3.After the coil did not detach at the syringe green zone, it was attempted to deploy the coil at the syringe red alternative detachment zone.Prior to attempting to detach, it was verified under fluoro that there was no stress against the microcatheter or delivery tube.The syringe pressurized as intended.There was no neck remodeling utilized.It was not necessary to remove the microcatheter.The coil was still attached to the coil delivery system when removed from the patient.There was no allegation of patient injury due to an alleged product issue.
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Updated sections on this medwatch: b4, g3, g6, h2, 3, h6 and h11.The device was returned to j&j medtech for further evaluation.A non-sterile orbit galaxy coil was received contained in the decontamination pouch.Upon receiving the device, visual inspection was performed, and no appearance of damages was observed.The coil was still attached to the gripper.No further damages were observed under magnification nor under x-ray imaging.The orbit galaxy was attached to a lab sample trufill dcs syringe, then the pressure was increased in the syringe by rotating the syringe knob clockwise until the gauge indicator reach the green zone; however, the coil was not detaching.A manufacturing record evaluation was performed, and no non-conformances related to the reported complaint condition were identified.The issue reported regarding the failure to detach the coil was confirmed.With the limited information available, a conclusive cause cannot be determined; however, it is possible that clinical and procedural factors may have contributed to the reported failure, since according to risk documentation, an embolic coil not detaching is a potential failure mode that can occur due to multiple causes, including: improper syringe to hub connection.The syringe latch mechanism not held in place / not returned to the locked position after purging.Distal end of the microcatheter and delivery tube being stressed during detachment.Failure to use alternative detachment procedure.Contamination in the syringe from the syringe prepping procedure.Contamination in the hub preventing proper functioning of the device.At this time, there is no evidence to support that the issue reported in the complaint is 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 required.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) does contain the following recommendations: coil detachment must be confirmed under fluoroscopy by releasing the second rhv and slowly retracting the delivery tube ensuring that the coil is not being retracted into the tip of the infusion catheter and that the delivery tube marker bands move away from the coil without resistance.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
Additional Manufacturer Narrative
Manufacturer reference number: (b)(4).Updated sections on this medwatch: b4, d9, g3, g6, h2, h3, and h11.The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed a supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: ORBIT GALAXY
• 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. (JUAREZ); circuito interior norte #1820; parque industrial salvarcar; juarez chihuahua 32574 ; MX 32574
• Manufacturer Contact: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 24664590
• Report Number: 3008114965-2026-00446
• Device Sequence Number: 18441213
• Product Code: KRD
• UDI-Device Identifier: 10886704030331
• UDI-Public: (01)10886704030331(17)270331(10)31638655
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K093973
• 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): 04/27/2026

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: 640CF0615
• Device Lot Number: 31638655
• 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: 03/12/2026
• Supplement Date Received by Manufacturer: 04/20/2026; 04/24/2026
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 04/21/2026; 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2025
• 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