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

Catalog Number	640CX0306
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The healthcare professional reported that during an endovascular embolization procedure, the shape of the 3mm x 6cm orbit galaxy complex xtrasoft (640cx0306 / 31485464) was found to be not ideal after it was used to fill the aneurysm.The physician retracted only the coil, but the oil was found to be unraveled / stretched.The physician replaced the coil with one from another brand to complete the procedure using the same original microcatheter (unspecified brand).There was no report of any negative patient impact.On 26-nov-2025, additional information was received.Per the information, the procedure was targeting a tortuous and narrow aneurysm on the left internal carotid artery.No neck remodeling was used; a continuous flush had been maintained through the microcatheter.The coil had been withdrawn and repositioned (the number of times this had been done was not provided).There was no resistance between the guidewire and the microcatheter when the target site was being accessed.Prior to this coil, one other coil went through the microcatheter without resistance.Information related to coil entanglement with previously placed coil could not be obtained.There was no additional damage noted on the coil aside from the reported stretched / unraveled condition when the coil was removed.The coil was not detached from the delivery system.The information confirmed there was no negative impact on the patient and no clinically significant delay in the procedure due to the reported issue.
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 is not available / reported.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: (31485464) 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 05-jan-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 complaint product was returned and received for evaluation and analysis.The investigation is documented below.Investigation summary: a non-sterile 3mm x 6cm orbit galaxy complex xtrasoft was received contained in the decontamination pouch.Visual inspection was performed.The embolic coil component was observed to be partially outside of the introducer.Microscopic inspection was performed.Under magnification, the embolic coil was observed to be severely stretched causing the internal blue resistance fiber exposed.The coil remains attached to the headpiece.The issue regarding the coil being stretched was confirmed during the microscopic inspection.The kinked and stretched conditions suggest that the device was forcibly advanced through the microcatheter during placement.Coil stretching and kinking are known potential issues associated with the use of this device.The instruction for use (ifu) provides proper handling instructions for the device to prevent such issues from occurring.According to the risk documentation, a coil being stretched is a potential issue that can occur during microcoil placement due to excessive system manipulation.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.A review of manufacturing documentation associated with this lot (31485464) 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 is multifactorial.The instruction for use (ifu) contains 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.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.Updated sections: b.4, 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.

• 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: 23707851
• Report Number: 3008114965-2025-01317
• Device Sequence Number: 10720266
• Product Code: KRD
• UDI-Device Identifier: 10886704030591
• UDI-Public: (01)10886704030591(17)260930(10)31485464
• 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): 01/08/2026

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: 09/30/2026
• Device Catalogue Number: 640CX0306
• Device Lot Number: 31485464
• 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: 11/24/2025
• Supplement Date Received by Manufacturer: 01/05/2026; 01/08/2026
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 01/05/2026; 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2024
• 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: MICROCATHETER (UNSPECIFIED BRAND).
• Patient Sex: Unknown