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

Model Number GLM910010

Device Problem Separation Failure (2547)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/24/2021

Event Type  malfunction  

Event Description

The healthcare professional reported that during an endovascular embolization procedure, the physician tried to detach the 1.00mm x 1.00cm galaxy g3 mini coil (glm910010 / 30483240) 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.

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 (30483240) 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.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.

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 (b)(6) 2022.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.

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 1.00cm galaxy g3 mini coil (glm910010 / 30483240) 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 product was returned and received for evaluation and analysis.The investigational finding is documented below.Investigation summary: a non-sterile 1.00mm x 1.00cm galaxy g3 mini coil was received contained in a pouch.Visual inspection was performed.The coil system showed no apparent damage.The embolic coil component was noted as still attached to the delivery system.Microscopic inspection was performed.Under magnification, the resistance heating (rh) coil showed no evidence of having been heated.The embolic coil was noted to have nonconcentric loops.Functional evaluation and analysis was performed.The resistance of the returned complaint device was measured with a multimeter.The resistance was measured to be approximately 52.0 o.This is within the specification range of 48.5 o ¿ 56.0 o.The complaint device was connected a lab sample detachment control box (dcb) and a lab sample enpower control cable.The power was turned on.The system ready light illuminated.The detachment cycle was initiated and the coil detached without issue.The rh coil showed evidence that heat was applied on it.A review of manufacturing documentation associated with this lot (30483240) 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 documented that during an endovascular embolization procedure, the physician tried to detach the 1.00mm x 1.00cm galaxy g3 mini coil several times, but the coil failed to detach.The reported issue related to the coil failing to detach during the procedure could not be confirmed.Visual inspection noted that the embolic coil was still attached to the delivery system.Under magnification, the rh coil showed no evidence that it had been heated.The resistance of the device was then measured and confirmed to be within the specification range.The complaint device underwent functional testing and the embolic coil detached without any difficulty.The nonconcentric loops observed on the embolic coil may have been the result of device handling during the procedure.This observation of the nonconcentric loops is not a contributing factor to the reported issue that the coil failed to detach.Although the reported issue was not confirmed and the returned complaint device detached without issue during the functional test, there may have been other issues during the procedure that could not be replicated in the laboratory environment during the functional evaluation.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) contains 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 micro coil as described in the following section, 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 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.

• Brand Name: GALAXY G3 MINI 1MM X 1CM
• Type of Device: 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 ; 949789-868
• MDR Report Key: 13063771
• MDR Text Key: 286935777
• Report Number: 3008114965-2021-00659
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 10886704080213
• UDI-Public: 10886704080213
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K171862
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/11/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: GLM910010
• Device Catalogue Number: GLM910010
• Device Lot Number: 30483240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2021
• Initial Date FDA Received: 12/22/2021
• Supplement Dates Manufacturer Received: 01/11/2022; 02/11/2022
• Supplement Dates FDA Received: 01/11/2022; 02/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: EXCELSIOR® SL-10® MICROCATHETER (STRYKER)