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

Catalog Number	640CX2505
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The healthcare professional reported that during a stent-assisted endovascular embolization procedure on (b)(6) 2026, the microcatheter was in place and the 8mm x 24cm orbit galaxy complex fill (640cf0824 / 31651278) was delivered to the target site.The coil filled the aneurysm, and the physician tried to detach the coil, but the coil was unable to be detached.The physician retracted only the coil and replaced it with a second coil, a 2.5mm x 5cm orbit galaxy complex xtrasoft (640cx2505 / 31661861).The second coil encountered the same issue; it was unable to be detached.The physician retracted the coil and replaced it with a third coil from another manufacturer to complete the procedure using the original microcatheter.There was no report of any negative impact on the patient.On 01-apr-2026, additional information was received.Per the information, the procedure was a stent-assisted coil embolization of an aneurysm on the internal carotid artery.The coils were not stretched when they were removed; they were still attached to the delivery systems.There was no interruption of blood flow.The syringe was filled with saline from a dedicated source.The same syringe was used with both coils.Before attempting to deploy the coils, the syringe had previously exceeded the green zone / position 3.It was verified under fluoro that there was no stress against the microcatheter or delivery tube prior to the attempt to detach.The coils were prepped without difficulty.With the attempts to deploy the coils, the syringe was taken to the red alternative detachment zone beyond the green zone after it did not detach in the green zone.The syringe did pressurize as intended when taken to the green zone.Nothing else was done in attempt to detach the coils.The information confirmed there was no negative patient impact and no procedure delay.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (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: (31661861) 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.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 on 29-apr-2026.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 2.5mm x 5cm orbit galaxy complex xtrasoft was received contained in the decontamination pouch.Visual inspection was performed.The embolic coil was no longer attached to the delivery system.Microscopic inspection revealed no damages.The issue documented that the coil failed to detach could not be confirmed as the coil was noted to be already detached from the system.Additionally, no product defect was identified; there may have been other circumstances or issues that occurred during the use of the device that could not be replicated in the lab setting.The instruction for use (ifu) provides proper handling instructions for the device to prevent such issues from occurring.A review of manufacturing documentation associated with this lot (31661861) 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 product failure could be caused by multiple factors.The instruction for use (ifu) does contain the following recommendation: ¿ 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.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.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: ORBIT GALAXY XTRASOFT
• 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 ; 949788-2078
• MDR Report Key: 24767328
• Report Number: 3008114965-2026-00438
• Device Sequence Number: 13331006
• Product Code: KRD
• UDI-Device Identifier: 10886704030652
• UDI-Public: (01)10886704030652(17)270430(10)31661861
• 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): 04/30/2026

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: 640CX2505
• Device Lot Number: 31661861
• 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: 03/17/2026
• Supplement Date Received by Manufacturer: 04/29/2026; 04/30/2026
• Initial Report FDA Received Date: 04/02/2026
• Supplement Report FDA Received Date: 04/29/2026; 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2025
• 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