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

Catalog Number	640CX0408
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to the procedure, the packaging of a 4x8 orbit galaxy xtrasoft coil (640cx0408, 31438250) was inspected and found in in good condition.The physician planned to deliver the coil and observed that fluid escaped from the coil introducer.The device was not used in the patient.The doctor switched to a new one to complete the surgery.The microcatheter was not replaced.There was no patient injury reported.Additional event information states that the event did not result in any undue procedural delay that could be considered clinically significant.No damage to the device¿s packaging was reported.No difficulties in removing the device from packaging was reported.Based on the product analysis of the device received, the embolic coil was found stretched.
Additional Manufacturer Narrative
Manufacturer ref# (b)(4) the purpose of this mdr submission is to report the findings of the device investigation.The embolic coil was stretched, meeting regulatory reporting criteria.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Section d2b ¿ procode: krd/hcg.The device was returned to j&j medtech for further evaluation.A non-sterile og cmplx xtrasoft coil 4x8 was received contained in the decontamination pouch.Upon receiving the device, visual inspection was performed, and the introducer was not returned for evaluation.Microscopic inspection was performed, and the coil component was noted to be stretched on the proximal portion, and as a result of stretching the internal blue fiber was exposed.The issue reported regarding fluid escaped from the coil introducer could not be evaluated through functional testing due to the condition of the returned device.The condition in which the device was returned was not originally reported in the complaint, and the exact time when this condition occurred could not be determined with the amount of information available.Although no conclusion could be reached as to the cause of the event as reported, there may have been other issues or circumstances that precluded the intended use of the device.There is no indication that the issue reported is a result of a defect inherently related to the device.Coil stretching is a known potential issue associated with the use of this device.The instructions for use (ifu) provide proper handling instructions for the device to prevent such issues from occurring.Stretching can occur during device handling where force may have been inadvertently applied.Coil stretching was not originally reported in the complaint and the exact time of occurrence cannot be determined, however, this condition is not considered related to the encountered issue.The introducer component might have gotten lost sometime during the post-operative handling of the device.If additional information or components are received at a later time, this investigation will be reassessed accordingly.A manufacturing record evaluation was performed for the finished device, and no non-conformances related to the reported complaint condition were identified.As part of the j&j medtech quality process, all devices are manufactured, inspected, and released to approved specifications.Since there is no evidence to suggest that the issue encountered during the procedure is related to the design or manufacture of the device, no capa activity is required.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) do contain the following recommendations: ¿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 (and/or part 4, as applicable).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 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 ; 9497882078
• MDR Report Key: 23004277
• Report Number: 3008114965-2025-00975
• Device Sequence Number: 21199526
• Product Code: KRD
• UDI-Device Identifier: 10886704030638
• UDI-Public: (01)10886704030638(17)260731(10)31438250
• 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): 09/09/2025

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: 07/31/2026
• Device Catalogue Number: 640CX0408
• Device Lot Number: 31438250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/28/2024
• 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
• Patient Sex: Unknown