MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 MINI 2MM X 6CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	GLM920060
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2024
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).Section h3 - 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.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.This is one of two products involved with the complaint and the associated manufacturer report numbers are 3008114965-2024-00356.
Event or Problem Description
As reported by the field, during a coil embolization to a left middle cerebral artery bifurcation aneurysm, a galaxy g3 mini 1.5mm x 2cm coil (glm915020, 30895987) was delivered in place.Fault light was illuminated, and the coil couldn't be detached.A new detachment control box (dcb) and an enpower connecting cable were replaced, but the coil was still unable to detach.The physician retracted the coil from the patient and replaced it with a galaxy g3 mini 2mm x 6cm coil (glm920060, 30878424), but the same issue occurred.The physician retracted the replaced the coil and switched to another brand coil to complete the surgery.The microcatheter (other brand) was not replaced.The procedure was prolonged about 30 minutes, the delay was not clinically significant.Additional event information received on 21-mar-2024 indicated that both coils were still attached to the coil delivery system when removed from the patient.There was no damage to the coils when removed from the patient.The spring ring is damaged during recovery, and the spring ring cannot be fully recovered into the lead-in sheath.
Additional Manufacturer Narrative
Product complaint (b)(4).Complaint conclusion: as reported by the field, during a coil embolization to a left middle cerebral artery bifurcation aneurysm, a galaxy g3 mini 1.5mm x 2cm coil (glm915020, 30895987) was delivered in place.Fault light was illuminated, and the coil couldn't be detached.A new detachment control box (dcb) and an enpower connecting cable were replaced, but the coil was still unable to detach.The physician retracted the coil from patient and replaced it with a galaxy g3 mini 2mm x 6cm coil (glm920060, 30878424), but the same issue occurred.The physician retracted the replaced the coil and switched to another brand coil to complete the surgery.The microcatheter (other brand) was not replaced.The procedure was prolonged about 30 minutes, the delay was not clinically significant.Additional event information received on 21-mar-2024 indicated that both coils were still attached to the coil delivery system when removed from the patient.There was no damaged to the coils when removed from the patient.The spring ring is damaged during recovery, and the spring ring cannot be fully recovered into the lead-in sheath.A non-sterile galaxy g3 mini 2mm x 6cm was received contained in the decontamination pouch.Upon receiving the device, a visual inspection was performed, and it was noted that the coil was outside of the introducer.No other damages were found.The device was inspected under microscopic magnification, and the embolic coil was found severely stretched and still attached to the resistance heating (rh).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, 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 a lab sample 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 fault light was illuminated, and the coil couldn't be detached cannot be confirmed since the device met the electrical specification range and the coil was successfully detached.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) provide 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 dpu wire detachment zone/extended coil being positioned beyond the microcatheter tip, which can result in reported failure.The coil stretching was not originally reported in the complaint and is considered to have appeared during the post-operational handling of the device.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 issues from occurring.Stretching and kinking can occur during procedure handling where force may have been inadvertently applied.A manufacturing record evaluation was performed for the finished device 30878424 number, and no non-conformances related to the malfunction were identified.As part of the cerenovus 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 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.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: GALAXY G3 MINI 2MM X 6CM
• 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. (FREMONT); 47709 fremont blvd; fremont CA 94538
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 19012029
• Report Number: 3008114965-2024-00357
• Device Sequence Number: 14423084
• Product Code: KRD
• UDI-Device Identifier: 10886704080312
• UDI-Public: 10886704080312
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K171862
• 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): 04/24/2024

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: 06/30/2025
• Device Catalogue Number: GLM920060
• Device Lot Number: 30878424
• 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: 03/14/2024
• Supplement Date Received by Manufacturer: 04/10/2024
• Initial Report FDA Received Date: 04/01/2024
• Supplement Report FDA Received Date: 04/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2022
• 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; GALAXY G3 MINI 1.5MM X 2CM; UNK DETACHMENT CONTROL BOX
• Patient Sex: Unknown