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

Catalog Number	640CF0510
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare professional reported that during a coil embolization, the physician attempted to advance a orbit galaxy coil (product code: 640cf0510, lot number: 31606031) through a microcatheter (non company brand).The coil became impeded at the proximal end of the microcatheter (mc) and could not be advanced further.The physician then retracted the coil without resistance, removed it from the system, and replaced it with a new coil.The procedure was completed successfully using the replacement coil.The microcatheter remained in use and was not exchanged.No patient injury or adverse clinical impact was reported.Additional event information received on 04-jan-2026 indicated that the event did not result in any undue procedural delay that could be considered clinically significant.The microcatheter was a sl-10.A synchro micro guide wire was successfully used with the microcatheter prior to or after the encountered resistance.The target vessel was the c7 segment (communicating segment) of the internal carotid artery.The vessel was relatively tortuous.The device did not appear damaged at any time.A continuous flush was maintained.The tip of the introducer was firmly installed into the hub of the microcatheter and locked with the rhv during device advancement.Based on the product analysis of the device received, the coil is kinked.
Additional Manufacturer Narrative
Manufacturer ref# (b)(4) the purpose of this mdr submission is to document the findings of the device investigation.The embolic coil was found to be kinked, which meets the applicable regulatory reporting criteria.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 og tdl cmplx fill coil 5x10 was received contained in the decontamination pouch.Upon receiving the device, a visual inspection was performed, and only the detached embolic coil was returned for evaluation.The coil was inspected under microscopic magnification, and multiple kinks were noted; however, it remained attached to the delivery system.Some dried blood residue was also observed.Even though the issue regarding a coil being impeded in the proximal end of the microcatheter cannot be evaluated through functional test, it can be confirmed based on the conditions in which the coil was returned.The kinked conditions noted on the embolic coil are considered to be secondary to the impeded condition encountered during the procedure where force may have been inadvertently applied to the device in an attempt to overcome the friction.Factors not described in the event description may have contributed to the issue encountered during the procedure; however, this cannot be conclusively determined.There is no indication that the issue reported in the complaint is a result of a defect inherently related to the device.As part of the j&j medtech quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device 31606031 number, and no internal actions related to the malfunction were identified.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) contains the following recommendations: never advance, withdraw, or torque the delivery tube against resistance without first determining the cause of resistance under fluoroscopy.Manipulation of the delivery tube against resistance can cause damage and/or premature detachment of the coil.If unusual friction is noted within the infusion catheter, remove the detachable coil system.If friction is noted with any subsequent detachable coil system, carefully examine the detachable coil system and the infusion catheter for possible damage.Replace both if necessary.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.

• 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: 24269323
• Report Number: 3008114965-2026-00241
• Device Sequence Number: 10120765
• Product Code: KRD
• UDI-Device Identifier: 10886704030294
• UDI-Public: (01)10886704030294(17)270228(10)31606031
• 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): 02/05/2026

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: 640CF0510
• Device Lot Number: 31606031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/13/2025
• 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: SL-10 MICROCATHETER (STRYKER)
• Patient Sex: Unknown