MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 MINI 1MM X 2CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number GLM910020

Device Problems Stretched (1601); Failure to Advance (2524)

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

Event Date 11/13/2023

Event Type  malfunction  

Event Description

The healthcare professional reported that during an endovascular embolization procedure, the complaint coil, a 1.00mm x 2.00cm galaxy g3 mini (glm910020 / 30778025) could not be advanced nor retrieved by the physician.The physician removed the coil and the concomitant microcatheter from the patient¿s anatomy to inspect; after inspection, the coil was observed in stretched condition.There was no negative patient impact reported.A photo of the complaint device was included in the complaint.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(6).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.Section d.2b: procode is krd/hcg.Section e.1: the name, phone and email address of the initial reporter are not available / reported.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.The product analysis team reviewed the photo of the complaint device.The review is documented below.[photo review]: the photo accompanying the complaint shows the galaxy g3 coil stretched and still attached to the resistance heating (rh) coil.The rest of the device cannot be observed in the photo and no further damages could be noted.A review of manufacturing documentation associated with this lot (30778025) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.The issue regarding a coil being stretched was confirmed based on the stretched condition seen in the coil, also, the issue regarding a coil not being able to be advanced nor retrieved was confirmed based on this condition since it may be the result of the impeding felt.This investigation was performed based only on the photo provided.If the product is received after this investigation, an assessment will be performed as per the conditions of the device returned.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.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.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 was received in the product analysis lab on 02-jan-2024.The returned product is pending evaluation.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.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigation finding of the returned device.The complaint device was returned for evaluation and analysis.The investigation finding is documented below.Investigation summary: a non-sterile 1.00mm x 2.00cm galaxy g3 mini was received contained in the decontamination pouch.Visual inspection was performed.It was noted that the embolic coil was severely stretched, as observed in the photo included in the complaint.In addition, it was noted that the embolic coil had snapped into two separate fragments due to the severity of the stretching.This condition was not noted in the photo.The proximal aspect of the core wire had two kinks at 72 cm and 103 cm from the connector hub.No additional components were returned, and no further appearance of damage was observed.Microscopic inspection was performed.Under magnification, it was confirmed that the proximal fragment of the embolic coil remained attached to the resistance heating (rh) coil.The core wire was kinked just proximal and distal to the marker band.The issue reported that the coil could not be advanced nor retrieved cannot be evaluated through functional test due to the condition of the embolic coil and the lack of components returned; however, the damages observed on the embolic coil and core wire suggest that the device was subjected to excessive manipulation when trying to advance and retrieve the coil.The issue reported that the coil was in a stretched condition was confirmed based on the appearance of the returned device.Continuous saline flush not established during microcoil placement is a potential failure mode that can result in friction/difficulty to advance; rotative hemostasis valve (rhv) fastened too tightly, and introducer tip and microcatheter hub misalignment during microcoil placement are potential failure modes can result in device damage.The use of incompatible ancillary devices and user technique may have contributed to the issue encountered.The kinks observed on the proximal core wire were not originally reported and were found too proximal to have contributed or be secondary to the difficulty in advancing/retrieving the device.The most likely time of occurrence is during the post-operative handling and shipping of the device.A review of manufacturing documentation associated with this lot (30778025) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) do contain the following recommendations: if unusual friction is noticed during advancement or retraction of the microcoil system, verify the locking mechanism, or clear tab is unlocked and pulled out from the re-sheathing tool approximately 1 in (2-3 cm).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.After flushing, reinsert the introducer into the infusion catheter hub.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 the microcoil system becomes immobile in the microcatheter, apply a gentle push-pull motion to free it.If unsuccessful, remove both microcatheter and microcoil system together as a unit and replace with new devices.If the microcoil is positioned at a relative sharp angle to the microcatheter, a microcoil may stretch or break as it is being withdrawn.By repositioning the distal tip of the microcatheter at or slightly inside the ostium (neck) of the aneurysm, the microcoil may be more easily funneled back into the microcatheter.Pulling the exposed microcoil through the rhv grommet may damage the coil.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 1MM X 2CM
• 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): CERENOVUS INC. (FREMONT); 47709 fremont blvd; fremont CA 94538
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-689
• MDR Report Key: 18259338
• MDR Text Key: 330132838
• Report Number: 3008114965-2023-00841
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 10886704080237
• UDI-Public: 10886704080237
• 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: 02/08/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: GLM910020
• Device Lot Number: 30778025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/13/2023
• Initial Date FDA Received: 12/04/2023
• Supplement Dates Manufacturer Received: 01/02/2024; 02/08/2024
• Supplement Dates FDA Received: 01/02/2024; 02/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2022
• 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