MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 MINI 1.5MM X 2CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	GLM915020
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, weight, race, and ethnicity were not provided.Section d.2b: procode is krd/hcg.Section e.1: the initial reporter phone: (b)(6).Section h.3: 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 (30895979) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.This report is being submitted pursuant to the provisions of 21 cfr, part 803.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.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.
Event or Problem Description
The healthcare professional reported that the 48-year-old male patient underwent an endovascular embolization procedure.During the procedure, the complaint device, a 1.50mm x 2.00cm galaxy g3 mini coil (glm915020 / 30895979) filled in the aneurysm.The system ready light did not illuminate when the coil system was connected via the control cable to the detachment control box.After several attempts, the system ready light still did not illuminate.The physician removed the coil from the patient and switched to a competitor brand coil to complete the procedure.The procedure was prolonged by approximately 30 minutes.There was no negative patient impact reported.On 23-nov-2023, additional information was received.In response to the question about the intended procedure / target vessel, the information provided a procedure image which is pending independent physician review.The information indicated that the coil was still attached to the delivery system when it was removed from the patient.The microcatheter used was a headway® 17 microcatheter (microvention).The same microcatheter was used to complete the procedure.Information related to if a pre-deployment electrical check was performed could not be obtained.The fault light was not seen during the procedure.During the detachment cycle, the detachment light did not illuminate and the audible signal beep was not heard.The information confirmed there was no negative patient impact and the 30-minute procedure extension was not clinically significant.
Additional 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 06-dec-2023.A supplemental 3500a report will be submitted once the product investigation has been completed.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 include the medical image review completed on (b)(6) 2023.The procedure image included in the complaint underwent independent physician review.The assessment is documented below.¿the description of the event is clear.There does not seem to be any patient harm.In this case the image does not provide additional information.Non-illumination of the system light can be the result of failure of the detachment box or a disconnect in the cable or coil itself.Given the fact that after replacement of the coil the light worked as expected, the issue must have been caused by the coil system.If the coil is sent back to the r&d team it can be analyzed for further understanding.The description nor the image help in finding the root cause at this time.¿.Physician name and date reviewed: md, (b)(6) msc, (b)(6) 2023.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 the investigation finding of the returned device.Investigation summary: a non-sterile 1.50mm x 2.00cm galaxy g3 mini coil was received contained in the decontamination pouch.Visual inspection was performed.The proximal end of the embolic coil was observed severely stretched.No other damages were observed.Microscopic inspection revealed that due to the severity of the stretched condition of the embolic coil, the blue fiber was exposed.The embolic coil was still attached to the articulating joint, and the distal outer sheath had not been softened, indicating that the resistance heating (rh) coil had not been heated and the detachment process was not initiated.The electrical resistance of the 1.50mm x 2.00cm galaxy g3 mini coil was measured with a multimeter, and no values were obtained.Also, the device was connected to a lab sample detachment control box (dcb) dcb00000500, and the power was turned on.The system ready light was not illuminating.A manufacturing record evaluation was performed, and no non-conformances related to the reported complaint condition were identified.The device history records (dhr) for lot number 30895979 were reviewed and no evidence of deficiencies during the manufacturing process was found.No non-conformances were generated during the manufacturing process.Complaint history for lot number 30895979 found no similar failures observed.The issue reported regarding the system ready light not illuminating was confirmed.The device did not present any physical damage (cuts or severe kinks) to the shaft of the device positioning unit (dpu) to cause electrical issues.Another place for electrical issues would be at either connection point ¿ at the proximal connector where the pins are soldered or at the distal connection near to or inside the rh heater, however, all components were inspected, and no anomalies were observed.It is possible that other factors such as device manipulation, may have caused the electrical failure that led to the failure to detach.The stretched condition of the embolic coil was not originally reported, and the exact time of occurrence cannot be determined; however, it is suggested that this condition could be related to the post-operative handling/inspection of the device, and it is not related to the issue encountered during the procedure.As part of cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.Devices undergo 100% electrical continuity test for finished product prior to pouching and boxing to prevent failure to detach from occurring during the procedure.It should be noted that product failure could be caused by multiple factors.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 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 as described in the following section, re sheathing the microcoil system, and replace with a new microcoil system.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.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 1.5MM X 2CM
• 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 ; 303552-6892
• MDR Report Key: 18262701
• Report Number: 3008114965-2023-00854
• Device Sequence Number: 7672756
• Product Code: KRD
• UDI-Device Identifier: 10886704080138
• UDI-Public: 10886704080138
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/08/2024

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: 07/31/2025
• Device Catalogue Number: GLM915020
• Device Lot Number: 30895979
• 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: 11/14/2023
• Supplement Date Received by Manufacturer: 12/07/2023; 12/14/2023; 02/08/2024
• Initial Report FDA Received Date: 12/04/2023
• Supplement Report FDA Received Date: 12/07/2023; 01/02/2024; 02/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2022
• 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 DCB 2; HEADWAY® 17 MICROCATHETER (MICROVENTION).; UNK CONNECTING CABLE.
• Patient Age: 48 YR
• Patient Sex: Male