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

Catalog Number	640CF1030
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The healthcare professional reported that during a procedure, the 5mm x 15cm orbit galaxy complex fill coil (640cf0515/31613390) encountered a lot of resistance and became bent and the delivery wire ¿got broken.¿ it was also reported that the 10mm x 30cm orbit galaxy complex fill coil (640cf1030/31467308) encountered resistance during the coil advancement.The 132cm embovac 71 aspiration catheter (ic71132ca/31411520) got stuck in the hoop.The procedure was delayed by 15 minutes.It was successfully completed by using ¿another catheter and coils.¿ there was no report of any negative patient impact.Based on the event description, the issue reported with the 5mm x 15cm orbit galaxy complex fill coil (640cf0515/31613390) meets usfda reporting criteria a classification of ¿malfunction.¿ the complaint devices were returned for evaluation and analysis.Based on the result of the product analysis completed on 09-jan-2026, the reported issue related to the 10mm x 30cm orbit galaxy complex fill coil (640cf1030/31467308) meets usfda reporting criteria under 21 cfr 803 as a "malfunction.".
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).The complaint product was returned and received for evaluation and analysis.The investigation is documented below.Investigation summary: a non-sterile 10mm x 30cm orbit galaxy complex fill coil was received contained in the decontamination pouch.Visual inspection was performed.The embolic coil was noted to be outside of the introducer.Microscopic inspection was performed.Under magnification, the embolic coil was found severely stretched leaving the internal blue fiber exposed.However, the coil was still attached to the gripper.The issue documented in the complaint that resistance was felt during the advancement of the coil could not be evaluated through proper functional test since the stretched condition found on the coil prevented the ability to move the coil through the introducer.The coil stretching was not originally reported in the complaint.Such damage suggests that excessive force was inadvertently applied during the attempts to withdraw and re-insert the device.It is possible that clinical and procedural factors, including device manipulation and operator's technique, may have contributed to the reported failure.According to the risk documentation, coil damage is a potential issue that can occur during microcoil placement due to excessive system manipulation, which can result in coil stretching.The reported issue documented in the complaint is confirmed based on the findings documented in this investigation.In addition, the risk documentation states that a delivery tube / embolic coil that cannot be pushed through the microcatheter is a potential issue that can occur during coil placement due to 1) excessively tortuous anatomy; or 2) clot formation in the microcatheter.With the 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.A review of manufacturing documentation associated with this lot (31467308) 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 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.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.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
• 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: 24063816
• Report Number: 3008114965-2026-00156
• Device Sequence Number: 9130429
• Product Code: KRD
• UDI-Device Identifier: 10886704030416
• UDI-Public: (01)10886704030416(17)260930(10)31467308
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 01/13/2026

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: 640CF1030
• Device Lot Number: 31467308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2024
• 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