MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	GLM920040
Medical Device Problem Codes	Stretched (1601); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The healthcare professional reported that during an endovascular embolization procedure, the coil shape of the 2.00mm x 4.00cm galaxy g3 mini (glm920040 / 30937895) was found not ideal after it filled in the aneurysm.The physician retracted the coil and delivered it again, but the coil was impeded in the tip of the microcatheter and could not be further advanced.The physician retracted only the coil and found that the coil had become unraveled / stretched.The physician replaced the coil and successfully filled the aneurysm with the replacement coil.There was no report of any negative patient impact.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, sex, gender, 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.If the device returns, a device investigation will be performed.A review of manufacturing documentation associated with this lot (30937895) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no internal actions 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 johnson & johnson medtech, or its employees that the report constitutes an admission that the product, johnson & johnson medtech, 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.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 18-feb-2025.[additional information]: on 18-feb-2025, additional information was received.Per the information, the target vessel was the middle cerebral artery (mca).The targeted aneurysm was a bifurcation aneurysm (no other information was provided on the aneurysm size and characteristics).A continuous flush was maintained through the microcatheter.The information indicated that the coil had been withdrawn and repositioned once.There was no resistance between the guidewire and the microcatheter when the target site was being accessed.The coil was impeded in the microcatheter tip and could not advance further.Coil entanglement with previously placed coil was not suspected as a contributing factor to the reported stretched condition of the coil.The information indicated that the coil was not detached, ¿the doctor retracted the coil alone, but the coil was found unraveled / stretched.¿ there was no blood flow restriction / reduction as a result of the reported issue.The information confirmed there was no negative impact to the patient and no delay in the procedure.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 multiple attempts to obtain product for analysis were unsuccessful.If product is returned or information provided at a later date, the file will be updated accordingly.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.A review of manufacturing documentation associated with this lot (30937895) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no internal actions related to device manufacture or inspection.With the information available and without the complaint product available to be returned for analysis, the reported issue documented in the complaint cannot be confirmed through functional evaluation and analysis.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint sample; however, it is possible that clinical and procedural factors, including device manipulation / interaction may have contributed to the reported failure.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.Updated sections.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 investigational finding of the returned device.The complaint product was returned and received for evaluation and analysis.The investigation is documented below.Investigation summary: a non-sterile 2.00mm x 4.00cm galaxy g3 mini was received contained in the decontamination pouch.Visual inspection was performed.The device was returned inside the dispenser hoop.The embolic coil was advanced through the introducer, and the proximal end of the embolic coil was severely stretched with the blue fiber exposed.However, the coil remained attached to the resistance heating (rh).No other damages were noted in the device.The issue documented a coil that was impeded in the microcatheter and later found unraveled / stretched was confirmed based on the appearance of the returned device.The damages observed in the coil could be the result of the impeded condition experienced during the procedure.Stretching can occur during procedure handling where force may have been inadvertently applied.According to the risk documentation, friction and difficulty to advance are potential issues that can occur during microcoil placement due to continuous saline flush not being established, which can result in coil damage.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 issues from occurring.There is no indication that the issue reported is a result of a defect inherently related to the device.A review of manufacturing documentation associated with this lot (30937895) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no internal actions related to device manufacture or inspection.As part of johnson & johnson medtech quality process, all devices are manufactured, inspected, and released to approved specifications.It should be noted that multiple factors could cause product failure.The instructions for use (ifu) contains the following precautions: ¿ 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.If repositioning of the microcoil is necessary, carefully observe the motion of the microcoil in respect to the dpu wire while retracting the microcoil under fluoroscopy.If the microcoil movement is not one-to-one with the dpu wire, or if repositioning is difficult, the microcoil may have become stretched and could possibly break.Gently remove and discard the 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.Updated sections: b.4, g.3, g.6.H.2, h.3, h.6, and h.11.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 analysis lab received the complaint device on 27-mar-2025.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.

• Brand Name: GALAXY G3
• 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: 21284457
• Report Number: 3008114965-2025-00065
• Device Sequence Number: 12753039
• Product Code: KRD
• UDI-Device Identifier: 10886704080305
• UDI-Public: (01)10886704080305(11)221028(17)250930(10)30937895
• 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,Followup
• Report Date (Section B): 04/02/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2025
• Device Catalogue Number: GLM920040
• Device Lot Number: 30937895
• 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: 01/17/2025
• Supplement Date Received by Manufacturer: 02/18/2025; 02/17/2025; 03/27/2025; 04/02/2025
• Initial Report FDA Received Date: 01/31/2025
• Supplement Report FDA Received Date: 02/19/2025; 02/27/2025; 03/27/2025; 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2022
• 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: MICROCATHETER (UNSPECIFIED BRAND)
• Patient Sex: Unknown