MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 8MM X 24CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	GLY120824
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2023
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.Based on the analysis of the device received, the embolic coil was found kinked.The findings meet us regulatory reporting criteria.Section d2b ¿ procode: krd/hcg section e1.Initial reporter phone: (b)(6).A non-sterile galaxy g3 8mm x 24cm was received contained in the decontamination pouch.Upon receiving the device, a visual inspection was performed, and multiple kinked conditions were found in the core wire near to the distal marker band.The coil was returned outside from the introducer.The coil component was inspected under microscopic magnification, and it was found two kinked conditions.The coil is still in one piece, and it remains attached to the resistance heating (rh), and this was found not softened indicating that the detachment process was not initiated.The issue documented regarding strong resistance during insertion could not be evaluated through functional testing due to the returned condition of the coil and the corewire prevent the ability to move the coil through the introducer.Coil kinking 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.According to the risk documentation, friction and difficulty to advance are potential issues that can occur during microcoil insertion due to continuous saline flush not being established, which can result in coil and core wire kinking.The coil damage was not originally documented in the complaint; however, it could be the result of the difficulty experienced during the insertion that could not be replicated in the laboratory, and based on this the customer complaint was able to be confirmed.There is no indication that the issue reported is a result of a defect inherently related to the device.A manufacturing record evaluation was performed, and no non-conformances related to the reported complaint condition were identified.As part of cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.Devices undergo 100% inspection at different points during the manufacturing process to prevent damages such as coil damage from leaving the facility.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no capa activity is required.It should be noted that multiple factors could cause product failure.The instructions for use (ifu) does contain the following recommendations: ¿ if unusual friction is noticed during advancement or retraction of the microcoil system through the introducer, open the rhv main valve, and partially withdraw the distal end of the introducer to expose its tip within the rhv.Tighten the rhv main valve and flush the y-connector of the rhv with sterile saline and verify that fluid exits the slit in the clear portion of the introducer.¿ if unusual friction is still noticed during advancement or retraction of the microcoil system, verify flush lines are open and properly pressurized.Then slowly withdraw the entire microcoil system and examine for damage.Replace it with a new microcoil system.If friction still exists, withdraw and examine the delivery catheter 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.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 three products involved with the complaint and the associated manufacturer report numbers are 3008114965-2023-00943, 3008114965-2023-00944 and 3008114965-2024-00243.
Event or Problem Description
As reported by the field, after a lighthouse microcatheter (mc) was placed as per the instructions for use (ifu), coil embolization was initiated.A galaxy g3 8mm x 24cm coil (gly120824, 30530863) was inserted and got stuck inside the microcatheter (mc).The coil could not be advanced, so it was retrieved.Then, replaced with another new coil with the same size, which was implanted with no issues.After that, a few additional coils were implanted.A galaxy g3 5mm x 15cm coil (gly120515, 30860250) was used and wound.Attempted to detached, but the lamp did not illuminate and could not be detached when energized.Replaced with a second galaxy g3 5mm x 15cm coil (gly120515, lot unknown) but the lamp came on and off and was not stable.Since it was unclear whether the coil could be detached, the coil was retrieved and replaced with another coil of a different size and implanted.The procedure was successfully completed.There was no negative impact to the patient.It is unknown if a continuous flush was done.Additional information received on 08-dec-2023 indicated that the replaced coils were used successfully with the microcatheter prior to or after the encountered resistance.Based on the product investigation of the galaxy g3 8mm x 24cm, the embolic coil was found kinked.

• Brand Name: GALAXY G3 8MM X 24CM
• 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: 18739160
• Report Number: 3008114965-2024-00243
• Device Sequence Number: 20643815
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/20/2024

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: 02/29/2024
• Device Catalogue Number: GLY120824
• Device Lot Number: 30530863
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2024
• Initial Report FDA Received Date: 02/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2021
• 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: GALAXY G3 5MM X 15CM; LIGHTHOUSE MICROCATHETER
• Patient Sex: Unknown