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

Catalog Number	640CR0930
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2025
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 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.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.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.
Event or Problem Description
A healthcare professional reported that during a coil embolization, an unspecified microcatheter was in place and an orbit galaxy coil (640cr0930, 31557208) was delivered to target site.The coil was filled in the aneurysm and tried to detach, but the coil was unable to detach.The doctor only retracted the coil alone and switched to a new one to complete the surgery.The microcatheter was not replaced.Additional event information received on 19-aug-2025 indicated that a pre-deployment electrical testing was performed.There was neck remodeling used with a stent.The coil was still attached to the coil delivery system when removed from the patient.The embolic coil did not stretch or became damaged when removed from the patient.There was no allegation of patient injury due to an alleged product issue.
Additional Manufacturer Narrative
Manufacturer ref#(b)(4).Updated sections on this medwatch: b4, d9, g3, g6, h2, h3 and h11.The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.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: a healthcare professional reported that during a coil embolization, an unspecified microcatheter was in place and an orbit galaxy coil (640cr0930, 31557208) was delivered to target site.The coil was filled in the aneurysm and tried to detach, but the coil was unable to detach.The doctor only retracted the coil alone and switched to a new one to complete the surgery.The microcatheter was not replaced.Additional event information received on 19-aug-2025 indicated that a pre-deployment electrical testing was performed.There was neck remodeling used with a stent.The coil was still attached to the coil delivery system when removed from the patient.The embolic coil did not stretch or became damaged when removed from the patient.There was no allegation of patient injury due to an alleged product issue.The device was returned to j&j medtech for further evaluation.A non-sterile 9mm x 30cm orbit tdl complex frame coil was received contained in the decontamination pouch.Upon receiving the device, a visual inspection was performed, and no apparent damage was observed.The coil was noted to be still attached to the delivery system.The coil component was inspected under microscopic magnification; it was found that the proximal portion is severely stretched leaving the internal blue fiber exposed.The orbit galaxy was attached to a lab sample trufill dcs syringe, then the pressure was increased in the syringe by rotating the syringe knob clockwise until the gauge indicator reach the green zone, in approximately 3 seconds the pressure rapidly decreased indicating that the coil has been successfully detached.The functional test was performed successfully.Additionally, no damage was found on the orbit galaxy that could have contributed to the issue reported during the procedure.The customer complaint cannot be confirmed with the evidence available.It is possible that other clinical and procedural factors that cannot be replicated during the analysis may have contributed to the reported failure.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 issue from occurring.Stretching can occur during procedure handling where force may have been inadvertently applied.The stretched condition was not originally reported and may have occurred during the post operational handling of the device.This condition is not considered related to the reported issue.A manufacturing record evaluation was performed for the finished device, and no non-conformances related to the malfunction were identified.As part of the j&j medtech quality process, all devices are manufactured, inspected, and released to approved specifications.Therefore, no capa activity is required.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) does contain the following recommendations: ¿ coil detachment must be confirmed under fluoroscopy by releasing the second rhv and slowly retracting the delivery tube ensuring that the coil is not being retracted into the tip of the infusion catheter and that the delivery tube marker bands move away from the coil without resistance.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
• 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: 22951855
• Report Number: 3008114965-2025-00948
• Device Sequence Number: 9636153
• Product Code: KRD
• UDI-Device Identifier: 10886704030461
• UDI-Public: (01)10886704030461(17)261231(10)31557208
• 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): 09/26/2025

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 Catalogue Number: 640CR0930
• Device Lot Number: 31557208
• 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: 08/14/2025
• Supplement Date Received by Manufacturer: 09/22/2025; 09/24/2025
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 09/22/2025; 09/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2025
• 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