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

Catalog Number	640CX2535
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer ref#: (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Section d2b ¿ procode: krd/hcg.Section d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.Section h3 - 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.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
The healthcare professional reported that during a coil embolization, an orbit galaxy xtrasoft coil (product code: 640cx2535, lot number: unknown) couldn't be advanced nor retrieved by the physician.This was the first coil.No patient injury was reported.
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Updated sections on this medwatch: b4, d9, g3, g6, h2, h3, h6 and h11.The device was returned to j&j medtech for further evaluation.A non-sterile orbit galaxy xtrasoft 2.5x3.5 was received contained in the decontamination pouch.Upon receiving the device, visual inspection was performed, and it was noted that the support coil was protruding trough the introducer slit.The coil was inspected under magnification, and found to be in good condition (i.E., no kink, stretched or with non-concentric loops); this was noted to be still attached to the delivery system.The issue documented in the complaint that the coil couldn't be advanced nor retrieved could not be evaluated through a functional test due to the support coil condition; this condition prevents the ability of moving the coil through the introducer.With limited information available, the root cause remains speculative, however, there is no indication that the issues encountered during the procedure are a result of a defect inherently related to the device.It is possible that clinical and procedural factors, including device manipulation and operator's technique, may have contributed to the reported failure.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 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.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
Additional Manufacturer Narrative
Manufacturer ref# (b)(4) updated sections on this medwatch: b4, g3, g6, h2, h3, h6 and h11.Complaint conclusion: the healthcare professional reported that during a coil embolization, an orbit galaxy xtrasoft coil (product code: 640cx2535, lot number: unknown) couldn't be advanced nor retrieved by the physician.This was the first coil.No patient injury was reported.No additional information is available.Since no device has been received for analysis, no product investigation can be performed and the reported failure could not be evaluated.The lot number is not known; therefore, a device history record review cannot be completed.With the information available and without the product available for analysis, the reported customer complaint could not be confirmed.The exact cause of the event could not be determined; however, there are circumstances of the procedure that may have contributed to the reported failure.Coil withdrawal difficulty is a known potential issue associated with the use of the device.The instructions for use (ifu) contains instructions and cautions regarding proper placement of the device, including introduction and positioning of the microcoil.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• 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: 24199819
• Report Number: 3008114965-2026-00204
• Device Sequence Number: 9543988
• Product Code: KRD
• UDI-Device Identifier: 10886704030676
• UDI-Public: (01)10886704030676
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 03/05/2026

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: 640CX2535
• 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: 01/14/2026
• Supplement Date Received by Manufacturer: 02/10/2026; 02/16/2026
• Initial Report FDA Received Date: 01/28/2026
• Supplement Report FDA Received Date: 02/10/2026; 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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