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

Catalog Number	640CR0725
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2025
Type of Reportable Event	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 and email address are not available / reported.The complaint product was returned and received for evaluation and analysis.The investigation is documented below.Investigation summary: a non-sterile 7mm x 25cm orbit galaxy complex frame coil was received contained in the decontamination pouch.Visual inspection was performed.The hypo tube was observed to be broken.A kink was also noted on the hypo tube near the area where the device was noted to be broken.The coil was returned inside the introducer.Microscopic inspection was performed.The embolic coil was observed still attached to the delivery system.No damages were found on the coil (i.E., no elongations, no kinks, and no non-concentric loops).The reported issue regarding the coil sheath not being able to be re-sheath was confirmed since the kink damage found on the introducer prevented the zipper from advancing past the kink present on the introducer resulting in the inability to re-sheath the device.The issue regarding the impeded condition felt was confirmed based on the findings mentioned above.The broken condition appearance of the returned device suggests that it was subjected to excessive force to overcome the friction with the microcatheter.Factors not described in the event description, such as inadequate flush, may have contributed to the issue encountered during the procedure.There is no indication that the issue reported is a result of a defect inherently related to the device.A review of manufacturing documentation associated with this lot (31498857) 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) contains 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.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.
Event or Problem Description
The healthcare professional reported that during an endovascular embolization procedure, three (3) coils were used, an 8mm x 30cm orbit galaxy complex frame coil (640cr0830 / 31358781), a 7mm x 25cm orbit galaxy complex frame coil (640cr0725 / 31498857), and a 9mm x 25cm orbit galaxy complex frame coil (640cr0925 / lot unknown) encountered resistance and could not be resheathed.There was no report of any negative patient impact.On 11-sep-2025, additional information was received.Per the information, the endovascular embolization procedure was targeting the anterior cerebral artery (aca).There was no vessel calcification / tortuosity.The concomitant microcatheter used was a prowler 14 (catalog / lot number not provided).A continuous flush was maintained through the microcatheter.The introducer of the coil(s) was flushed until liquid was visible at the distal end of the slit int h clear tube.The tips of the introducer(s) were firmly installed into the hub of the microcatheter and locked with the rotating hemostasis valve (rhv) during the coil advancement.The issue the coils encountered was resistance while pushing in the microcatheter during the advancement; at the proximal part of the microcatheter.The microcatheter was not replaced; the same microcatheter was used with all three coils.There was no clinically significant delay in the procedure due to the reported issues.On 15-oct-2025, additional information was received.The information indicated that, ¿in some [coils] it was difficult to push inside the catheter and in one coil, it was difficult to resheath but now i don¿t remember the sizes.¿ based on the product investigation completed on 15-oct-2025, the issue reported associated with the 7mm x 25cm orbit galaxy complex frame coil (640cr0725 / 31498857) has been determined to be reportable as a "malfunction.".
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 03-feb-2026.[additional information]: on 03-feb-2026, additional information was received.The information included a correction to a coil that was also used during the procedure.This coil was documented in the initial 3500a medwatch, the issue encountered with this coil did not meet usfda reportability criteria; however, since it was used during the procedure and documented in the initial medwatch, the correction received is applicable.The coil was originally reported as a 9mm x 25cm orbit galaxy complex frame (640cr0925).The coil that was used was a 9mm x 25cm orbit galaxy complex fill (640cf0925).Updated sections: b.4, g.3, g.6, h.2, 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
• 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: 23312523
• Report Number: 3008114965-2025-01094
• Device Sequence Number: 4967161
• Product Code: KRD
• UDI-Device Identifier: 10886704030447
• UDI-Public: (01)10886704030447(17)261031(10)31498857
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2026

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: 640CR0725
• Device Lot Number: 31498857
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2025
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2024
• 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.
• Patient Sex: Unknown