MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 MINI 1MM X 1.5CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLM910015
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2021
Type of Reportable Event	Malfunction
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.Procode is krd/hcg.The name and email address of the initial reporter are not available / reported.The initial reporter phone: (b)(6).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 (30396204) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformance's related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
The healthcare professional reported that during an endovascular embolization procedure, the physician tried to detach the 1.00mm x 1.50cm galaxy g3 mini coil (glm910015 / 30396204) several times, but the coil failed to detach.The physician removed the coil and replaced it.There was no delay in the procedure as a result of the reported issue; the procedure was successfully completed.There was no report of any patient adverse event or complication.On 17 dec 2021, additional information was received.The information indicated that the procedure was an aneurysm coiling procedure.The complaint coil was successfully removed from the patient.It was not stretched when it was removed and it was still attached to the delivery system.The concomitant microcatheter used was an excelsior® sl-10® microcatheter (stryker); the same microcatheter was used to complete the procedure.The information also indicated that a pre-deployment electrical check was performed.No fault light was seen during the case.Upon pressing the power button, all the lights did illuminate and during the detachment cycle, the detachment light illuminated and the audible signal beep was heard.All connection fit properly without the application of force.The reported issue did not result in any clinically significant procedure delay.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigational finding of the returned device.[conclusion]: the healthcare professional reported that during an endovascular embolization procedure, the physician tried to detach the 1.00mm x 1.50cm galaxy g3 mini coil (glm910015 / 30396204) several times, but the coil failed to detach.The physician removed the coil and replaced it.There was no delay in the procedure as a result of the reported issue; the procedure was successfully completed.There was no report of any patient adverse event or complication.On 17-dec-2021, additional information was received.The information indicated that the procedure was an aneurysm coiling procedure.The complaint coil was successfully removed from the patient.It was not stretched when it was removed and it was still attached to the delivery system.The concomitant microcatheter used was an excelsior® sl-10® microcatheter (stryker); the same microcatheter was used to complete the procedure.The information also indicated that a pre-deployment electrical check was performed.No fault light was seen during the case.Upon pressing the power button, all the lights did illuminate and during the detachment cycle, the detachment light illuminated and the audible signal beep was heard.All connection fit properly without the application of force.The reported issue did not result in any clinically significant procedure delay.The complaint device was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: a non-sterile 1.00mm x 1.50cm galaxy g3 mini coil was received contained in a pouch.Visual inspection was performed.The core wire was observed kinked at 39 inches from the proximal end.Microscopic inspection was performed.Under magnification, the embolic coil was observed still attached to the delivery system as indicated in the additional information received on 17-dec-2021, which also indicated that the embolic coil was not stretched when it was removed.Under microscopic magnification, the embolic coil was observed to be in stretched condition.This observed stretched condition may have occurred during post-procedure handling or during shipping.The distal part of the resistance heating (rh) coil showed no evidence that it had been heated.The detachment fiber was closed, which indicated that the detachment process had not been initiated or it was not successfully initiated.Electrical resistance of the returned complaint device was measured to be 52.8 (ohms).This is within specification.The delivery positioning unit (dpu) was connected to a lab sample detachment control box (dcb) and the system ready light illuminated.The detachment button was pressed and the embolic coil detached without issue.A review of manufacturing documentation associated with this lot (30396204) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.The complaint reported that during the aneurysm coil embolization procedure, the physician tried to detach the complaint coil several times, but the coil failed to detach.The complaint device was returned and the reported issue related to the device failure to detach could not be confirmed through functional evaluation and analysis.The complaint device was returned still attached to the delivery system.Electrical resistance was measured and confirmed to be within specification.When it was connected to a lab sample dcb, the system ready light illuminated and when the detachment button was pressed, the complaint coil detached without issue.Although no functionality issue was identified, there may have been other factors or issues that occurred during the device use that may have contributed to the reported failure of the complaint device to detach that could not be replicated during the product analysis.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 persists, replace the connecting cable.If this does not correct the error, replace the dcb.If the microcoil delivery system continues to have a fault, retrieve the micro coil, and replace it with a new microcoil system.Coil stretching is a known potential issue associated with the use of this device.The instructions for use (ifu) provides proper handling instructions for the device to prevent such issue from occurring.Stretching can occur during procedure handling where force may have been inadvertently applied.The stretched condition of the embolic coil was not originally reported in the complaint.Additional information provided subsequent to the complaint initiation also confirmed that the coil was not in stretched condition when it was removed, therefore, the exact cause of the observed stretched condition of the embolic coil component cannot be conclusively determined.It is possible that the embolic coil component became stretched after during post-procedure handling or it may have become stretched during shipping.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.In addition, devices undergo 100% inspection at final assembly for the condition of the embolic coil.Thus, it is not likely that the 1.00mm x 1.50cm galaxy g3 mini coil left the manufacturing facility with the embolic coil in stretched condition as observed in the returned complaint device.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 was received by cerenovus product analysis lab on 22-feb-2022.The return product is pending evaluation.A supplemental 3500a report will be submitted once the product investigation has been completed.Updated sections: b.4, d.9, g.3, g.6.H.2, h.3, h.6, and h.10.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 MINI 1MM X 1.5CM
• 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 949789-8687
• MDR Report Key: 13063827
• Report Number: 3008114965-2021-00660
• Device Sequence Number: 19897473
• Product Code: KRD
• UDI-Device Identifier: 10886704080206
• UDI-Public: 10886704080206
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/04/2022

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: 05/31/2023
• Device Model Number: GLM910015
• Device Catalogue Number: GLM910015
• Device Lot Number: 30396204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2021
• Supplement Date Received by Manufacturer: 02/22/2022; 03/04/2022
• Initial Report FDA Received Date: 12/22/2021
• Supplement Report FDA Received Date: 02/22/2022; 03/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2020
• 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