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

Catalog Number	640CR0930
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer ref#: (b)(4).The purpose of this mdr submission is to report the findings of the device investigation.The coil is noted to be mechanically detached from the delivery system, meeting regulatory reporting criteria.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Section e1.Initial reporter phone: (b)(6).The device was returned to j&j medtech for further evaluation.A non-sterile og tdl cmplx frame coil 9x30 was received contained in the decontamination pouch.Upon receiving the device, visual inspection was performed, and the embolic coil was detached from the delivery system.The support coil were able to advance and retract from the introducer without significant resistance.Microscopic inspection revealed the gripper was mechanically detached from the support coil.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint condition were identified.The issue reported regarding the impeded condition of the embolic coil in the introducer could not be confirmed, as no resistance was met during advancing and retracting of the support coil.It is possible that clinical and procedural factors, including device manipulation and operator's technique, may have contributed to the reported failure.The mechanical detachment of the embolic coil was not originally reported, and the exact time of occurrence cannot be determined; therefore, this is not considered related to the issue reported.As part of j&j medtech quality process, all devices are manufactured, inspected, and released to approved specifications.Therefore, no internal action is required.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) contain the following precaution: if unusual friction is 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.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.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 an endovascular embolization, an orbit galaxy coil (product code: 640cr0930, lot number: 31359782) was impeded in the introducer and could not be pushed into a non-j&j microcatheter (mc).The physician only retracted the coil alone and switched to a new non-j&j coil to complete the procedure.The microcatheter was not replaced.No patient injuries nor consequences were reported.Additional information received indicated that the event did not result in any undue procedural delay that could be considered clinically significant.A ruikangtong 17 system microcatheter was used.The devices did not appear physically damaged at any time.Nothing was noted to be obstructing the introducer.A continuous flush was maintained.Based on the product analysis of the device received, the coil is noted to be mechanically detached from the delivery system.

• 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: 24121371
• Report Number: 3008114965-2026-00174
• Device Sequence Number: 13104275
• Product Code: KRD
• UDI-Device Identifier: 10886704030461
• UDI-Public: (01)10886704030461(17)260531(10)31359782
• 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
• Report Date (Section B): 01/20/2026

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 Expiration Date: 05/31/2026
• Device Catalogue Number: 640CR0930
• Device Lot Number: 31359782
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/07/2024
• 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: RUIKANGTONG 17 SYSTEM MICROCATHETER.
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 73 KG