MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 XSFT 4MM X 6CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLX120406
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by a healthcare professional, during a coil embolization procedure targeting an aneurysm located on the basilar artery, the complaint coil, a 4mm x 6cm galaxy g3 xsft coil (glx120406/30526856) was inserted into the excelsior® sl-10® microcatheter (stryker), but the coil got stuck on the microcatheter.The physician delivered wires to confirm if there was any malfunction inside of the microcatheter, and there were no problems.The issue occurred before the complaint coil was inserted into the patient.The complaint coil was replaced with another coil and the procedure was completed.It was reported that a continuous flush was done.On 29-mar-2023, additional information was received.The additional information indicated that it was not necessary to remove or replace the microcatheter.There was no damage reported in the device, and no excessive force had been applied.Based on the product analysis of the device received, the embolic coil is slightly stretched and with some kinked conditions.
Additional Manufacturer Narrative
Product complaint # (b)(4).The purpose of this mdr submission is to report the findings of the device investigation.The embolic coil was found stretched and kinked, meeting regulatory reporting criteria.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.A non-sterile 4mm x 6cm galaxy g3 xsft coil was received contained in the decontamination pouch.Upon receiving the device, visual inspection was performed, and the coil component was found outside of the introducer.Three (3) kinked conditions were found along the core wire, the first one was found at 96cm, the second one was found at 103cm and the third one was found at 174cm from the proximal end.The device was inspected under microscopic magnification, and it was found that the embolic coil is slightly stretched and with some kinked conditions; it remains attached to the resistance heating (rh) coil.The distal outer sheath had not been softened indicating that the resistance heating coil had not been heated and the detachment process was not initiated.No other damages were found in the device.Coil stretching and kinking are known potential issues 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.The stretched and kinked condition of the embolic coil were not originally reported in the complaint.All the damages noted in the device prevented the ability to move the coil to be evaluated through functional testing.According to the risk documentation, coil and device damage are potential issues that can occur during microcoil placement due to the rotative hemostasis valve (rhv) being fastened too tightly and the introducer tip and microcatheter hub being misaligned, which can result in coil stretching and kinking, and core wire kinking.However, other factors not described in the event description may have contributed to the issue encountered during the procedure.Based on this, the customer complaint regarding a coil impeding in the microcatheter was confirmed.With the information available there is no indication that the issue reported in the complaint results from 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 the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.Devices undergo 100% inspection at different points along the manufacturing process and at final assembly for the condition of the embolic coil and and other components such as the core wire.Thus, it is not likely that the complaint device left the manufacturing facility with the embolic coil in stretched and kinked condition and the core wire in kinked condition as noted during the microscopic inspection.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: do not fasten the rhv valve too tightly around the introducer sheath since excessive pressure may cause damage to the introducer sheath and/or the microcoil as it is advanced into the infusion microcatheter.Additionally, if the introducer tip and microcatheter hub are misaligned, damage may occur to the microcoil as it passes through this transition.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: GALAXY G3 XSFT 4MM 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): CODMAN & SHURTLEFF, INC. (FREMONT); 47709 fremont blvd; fremont CA 94538
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16960868
• Report Number: 3008114965-2023-00318
• Device Sequence Number: 5391837
• Product Code: KRD
• UDI-Device Identifier: 10886704077725
• UDI-Public: 10886704077725
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/19/2023

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: 01/31/2024
• Device Model Number: GLX120406
• Device Catalogue Number: GLX120406
• Device Lot Number: 30526856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2023
• Initial Report FDA Received Date: 05/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2021
• 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: EXCELSIOR® SL-10® MICROCATHETER (STRYKER).
• Patient Sex: Unknown