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

Catalog Number	640CX0202
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2025
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 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.The company is seeking this information through the event investigation.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, after a 2x2 orbit galaxy xtrasoft coil (640cx0202, 31487305) was filled in the aneurysm, the coil was impeded in the distal end of an unspecified microcatheter (mc) and could not be further filled.The doctor only retracted the coil alone and switched to a new coil to complete the surgery.The microcatheter was not replaced.The surgery was prolonged about 10 minutes.There was no patient injury reported.
Additional Manufacturer Narrative
Manufacturer ref# (b)(4) updated sections on this medwatch: b4, d9, g3, g6, h2, h3, h6 and h11.Complaint conclusion: a healthcare professional reported that during a coil embolization, after a 2x2 orbit galaxy xtrasoft coil (640cx0202, 31487305) was filled in the aneurysm, the coil was impeded in the distal end of an unspecified microcatheter (mc) and could not be further filled.The doctor only retracted the coil alone and switched to a new coil to complete the surgery.The microcatheter was not replaced.The surgery was prolonged by about 10 minutes.There was no patient injury reported.Additional event information received on 18-jul-2025 indicated that there was no difficulty positioning the coil.There was no evidence of physical material within the device.The microcatheter used was an echelon-10.The microcatheter did not kink/bent.There was no excessive force used with the devices.The 10 minutes procedure prolongation/delay did not result in a patient adverse consequence.The device was returned to j&j medtech for further evaluation.A non-sterile 2x2 orbit galaxy xtrasoft was received contained in the decontamination pouch.Upon receiving the device, a visual inspection was performed, and no damages or anomalies were observed.The coil was found outside of the introducer.The coil component was inspected under microscopic magnification, and it was noted to be in good condition (i.E., no elongations, kinks, or non-concentric loops were noted).The issue regarding a coil filling difficulty could not be evaluated since the reported issue is specific to the patient and procedure at the time of occurrence and cannot be replicated in the laboratory.However, positioning difficulty is a known potential issue associated with the use of the device.The instructions for use (ifu) provide proper handling instructions for the device to prevent such issues from occurring.A manufacturing record evaluation was performed for the finished device 31487305 number, 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) do contain the following recommendations: never advance, withdraw, or torque the delivery tube against resistance without first determining the cause of resistance under fluoroscopy.Manipulation of the delivery tube against resistance can cause damage and/or premature detachment of the coil.If friction is noted with any subsequent detachable coil system, carefully examine the detachable coil system and the infusion catheter for possible damage.Replace both if necessary.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, b5, g3, g6, h2, h11 and concomitant products.Section b5: additional event information received on 18-jul-2025 indicated that there was no difficulty positioning the coil.There was no evidence of physical material within the device.The microcatheter used was an echelon-10.The microcatheter did not kink/bent.There was no excessive force used with the devices.The 10 minutes procedure prolongation/delay did not result in a patient adverse consequence.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: 22460958
• Report Number: 3008114965-2025-00707
• Device Sequence Number: 18145528
• Product Code: KRD
• UDI-Device Identifier: 10886704030546
• UDI-Public: (01)10886704030546(17)260930(10)31487305
• 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): 08/20/2025

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: 09/30/2026
• Device Catalogue Number: 640CX0202
• Device Lot Number: 31487305
• 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: 07/02/2025
• Supplement Date Received by Manufacturer: 07/18/2025; 08/07/2025
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 07/18/2025; 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2024
• 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: ECHELON-10 MICROCATHETER.; MICROCATHETER.
• Patient Sex: Unknown