MAUDE Adverse Event Report: CERENOVUS, INC. GALAXY G3 8MM X 24CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	GLY120824
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The healthcare professional reported that during a coil embolization procedure of a subclavian artery after thoracic endovascular aortic repair (tevar), after stent graft implantation in the aorta, coil embolization of the subclavian artery was performed.During the implantation of the third coil, an 8mm x 24cm galaxy g3 (gly120824 / 30508870) was unable to be detached.The enpower control cable (ecb00018200 / 31000822) was replaced, but the issue was not resolved.The coil was retrieved and replaced with a new coil and the procedure was completed with the new coil.There was no negative impact on the patient.Continuous flush was not maintained.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, 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 initial reporter email address was not available / reported.Section h.3: the device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation.If the device returns, a device investigation will be performed.A review of manufacturing documentation associated with this lot (30508870) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.This report is being submitted pursuant to the provisions of 21 cfr, part 803.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.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.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 29-nov-2023.[additional information]: on 29-nov-2023, additional information was received.The information indicated that when the coil was not stretched when it was removed; it was no longer attached to the delivery system when it was removed.Per the information, ¿the coil was retrieved and replaced with another coil.¿ the replacement coil was another an 8mm x 24cm galaxy g3 (gly120824).Upon pressing the power button, all the lights did illuminate.The green system ready did illuminate.During the detachment cycle, the detachment light and the audible signal beep was not heard.All connections appeared to fit properly without application of force.The procedure was reportedly delayed by about 5 minutes but it was not considered clinically significant.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.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigation finding of the returned device.Investigation summary: a non-sterile 8mm x 24cm galaxy g3 was received contained in the decontamination pouch.Visual inspection was performed.It was observed that the coil was outside of the introducer.No other damages were found.The device was inspected under the microscope.The embolic coil was found still attached to the resistance heating (rh) coil.The distal outer sheath had not been softened, indicating that the detachment process was not initiated.The electrical resistance of the galaxy g3 device was measured with a multimeter, it measured 49.9 ohms (o), which is within the specification range between 48.5 ohms o ¿ 56.0 ohms o.Also, the device was connected to a lab sample detachment control box (dcb), and to the concomitant enpower control cable, and the power was turned on.The system ready light was illuminating.Then, the detach button was pressed, and a beep sound was heard.The coil was successfully detached from the unit.The issue documented that the coil failed to detach could not be confirmed since the device met the electrical specification range.Additionally, no product defect was identified; there may have been other circumstances or issues that occurred during the use of the device that could not be replicated in the lab setting.The instructions for use (ifu) provides proper handling instructions for the device to prevent such issues from occurring.According to the risk documentation, failure to detach is a potential issue that can occur during the coil detachment due to a detachment cycle not being initiated, as a result of the device positioning unit (dpu) wire detachment zone/extended coil being positioned beyond the microcatheter tip, which can result in reported failure.A review of manufacturing documentation associated with this lot (30508870) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.As part of the cerenovus 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 instructions for use (ifu) does contain the following recommendation: ¿ verify that the microcoil delivery system is fully connected, and no faults are indicated on the dcb.If a fault exists, reseat all connections between the dpu, the dcb, and the connecting cable.If a fault still persists, replace the connecting cable.If this does not correct the error, replace the dcb.If the microcoil delivery system still continues to have a fault, retrieve the microcoil, re sheathing the microcoil system, and replace it with a new microcoil 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.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.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product analysis lab received the complaint device on 06-dec-2023.A supplemental 3500a report will be submitted once the product investigation has been completed.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: GALAXY G3 8MM X 24CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): CERENOVUS, INC.; 6303 waterford district drive; suites 215 & 315; miami FL 33126
• Manufacturer (Section G): CERENOVUS INC. (FREMONT); 47709 fremont blvd; fremont CA 94538
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-6892
• MDR Report Key: 18145824
• Report Number: 3008114965-2023-00807
• Device Sequence Number: 20586967
• Product Code: KRD
• UDI-Device Identifier: 10886704077589
• UDI-Public: 10886704077589
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K150319
• 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,Followup,Followup
• Report Date (Section B): 01/05/2024

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: 12/31/2023
• Device Catalogue Number: GLY120824
• Device Lot Number: 30508870
• 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: 11/02/2023
• Supplement Date Received by Manufacturer: 11/29/2023; 12/06/2023; 01/05/2024
• Initial Report FDA Received Date: 11/15/2023
• Supplement Report FDA Received Date: 11/29/2023; 12/07/2023; 01/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2021
• 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: ENPOWER CONTROL CABLE; MICROCATHETER
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian