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

Catalog Number	640CF0620
Medical Device Problem Codes	Crack (1135); Device Difficult to Setup or Prepare (1487); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Section d2b ¿ procode: krd/hcg.Section e1.Initial reporter phone: (b)(6).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
As reported by the field, during an endovascular embolization to the posterior communicating artery, the physician filled the aneurysm with a 3x8 orbit galaxy xtrasoft coil (640cx0308, 31270225), it was found that the shape was not ideal (no further clarification was available).The physician started to retract the coil for adjusting, but the coil could not be retracted to the introducer sheath.Then, a new coil, 6x20 orbit galaxy (640cf0620, 31359780) was used to fill the aneurysm, but the same issue as the previous coil was encountered, which cannot be retracted into the introducer sheath.The doctor switched to non j&j coils to complete the surgery.The non j&j microcatheter was not replaced.The procedure was prolonged about 15 minutes.No patient injury was reported.Additional event information received on 20-dec-2024 indicated that poor conformability led to the re-sheathing of the coils.The coil introducer was cracked, no coil protrusion from introducer.The coils were not positioned at a relative sharp angle to the microcatheter.
Additional Manufacturer Narrative
Product complaint # (b)(4).Updated sections on this medwatch: b4, g3, g6, h2, h6 and h11.Complaint conclusion: as reported by the field, during an endovascular embolization to the posterior communicating artery, the physician filled the aneurysm with a 3x8 orbit galaxy xtrasoft coil (640cx0308, 31270225), it was found that the shape was not ideal (no further clarification was available).The physician started to retract the coil for adjusting, but the coil could not be retracted to the introducer sheath.Then, a new coil, 6x20 orbit galaxy (640cf0620, 31359780) was used to fill the aneurysm, but the same issue as the previous coil was encountered, which cannot be retracted into the introducer sheath.The doctor switched to non j&j coils to complete the surgery.The non j&j microcatheter was not replaced.The procedure was prolonged about 15 minutes.No patient injury was reported.Additional event information received on 20-dec-2024 indicated that poor conformability led to the re-sheathing of the coils.The coil introducer was cracked, no coil protrusion from introducer.The coils were not positioned at a relative sharp angle to the microcatheter.The device was discarded; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device 31359780 number, and no non-conformances related to the malfunction were identified.With the information available and without the product available for analysis, the reported customer complaint could not be confirmed.Based on the manufacturing record evaluation, there is no indication that the event is related to the device manufacturing process.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.The ifu instructs on proper positioning of the microcoil system.The ifu also warns: ¿if repositioning of the microcoil is necessary, carefully observe the motion of the microcoil in respect to the dpu wire while retracting the microcoil under fluoroscopy.If the microcoil movement is not one-to-one with the dpu wire, or if repositioning is difficult, the microcoil may have become stretched and could possibly break.Gently remove and discard the microcoil 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.

• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 21091508
• Report Number: 3008114965-2025-00020
• Device Sequence Number: 18325973
• Product Code: KRD
• UDI-Device Identifier: 10886704030348
• UDI-Public: (01)10886704030348(17)260531(10)31359780
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2025

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: 05/31/2026
• Device Catalogue Number: 640CF0620
• Device Lot Number: 31359780
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2024
• Supplement Date Received by Manufacturer: 02/06/2025
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/04/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MICROCATHETER (UNSPECIFIED BRAND).
• Patient Sex: Unknown