MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 MINI 2MM X 6CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	GLM920060
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the field, during an endovascular embolization to the middle cerebral artery, a galaxy g3 mini 2mm x 6cm coil (glm920060, 30889359) became impeded at distal end of the microcatheter (other brand) and could not pass through the microcatheter (mc).The doctor removed the coil from the patient's body and replaced it with a new coil to complete the surgery.The microcatheter was not replaced.There was no patient injury reported.Additional event information received on 21-jun-2024 indicated that the resistance was felt during advancement.The resistance was first felt inside the introducer sheath.The target vessel had no calcification, no tortuosity.The device did not appear damaged at any time.There was nothing noted to be obstructing the microcatheter.A continuous flush was maintained.The introducer was flushed until liquid was visible at the distal end of the slit in the clear tube.The tip of the introducer was firmly installed into the hub of the microcatheter and locked with the rhv during device advancement.Based on the product analysis of the device received, the embolic coil was found kinked.
Additional Manufacturer Narrative
Product complaint (b)(4).The purpose of this mdr submission is to report the findings of the device investigation.The embolic coil was kinked, meeting regulatory reporting criteria.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Section d2b ¿ procode: krd/hcg.Section e1.Initial reporter phone: (b)(6).A non-sterile galaxy g3 mini 2mm x 6cm was received contained in the decontamination pouch.Upon receiving the device, visual inspection was performed, and a portion of the embolic coil was protruding from the tip of the introducer.The core wire was noted to be kinked and protruding from the introducer.The embolic coil was inspected under microscopic magnification, and several slight kinks were noted along the entire length of the protruded coil.A manufacturing record evaluation was performed, and no non-conformances related to the reported complaint condition were identified.The issue documented regarding a coil being impeded in the distal section of the microcatheter could not be evaluated through functional testing due to the returned condition of the core wire; this prevented the ability to move the coil inside the introducer.According to the risk documentation, friction and difficulty to advance are potential issues that can occur during embolic coil insertion due to continuous saline flush not being established, which can result in the core wire being kinked.The kinking of the core wire was not originally documented in the complaint; however, it could be the result of the difficulty experienced during the procedure that could not be replicated in the laboratory, and based on this the customer complaint was able to be confirmed.There is no indication that the issue reported is a result of a defect inherently related to the device.The kinked conditions of the embolic coil were not originally reported; however, since the kinks were found on the protruded area of the embolic coil in the introducer, it is suggested that these damages could be the result of the post-handling of the device, thus, are not considered related to the issue reported.As part of cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.Devices undergo 100% inspection at different points during the manufacturing process to prevent damage from leaving the facility.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no capa activity is required.It should be noted that multiple factors could cause product failure.The instructions for use (ifu) does contain the following recommendations: ¿ 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.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.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.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.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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.

• Brand Name: GALAXY G3 MINI 2MM X 6CM
• 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 ; 3035526892
• MDR Report Key: 19826296
• Report Number: 3008114965-2024-00739
• Device Sequence Number: 18338118
• Product Code: KRD
• UDI-Device Identifier: 10886704080312
• UDI-Public: (01)10886704080312(11)220813(17)250731(10)30889359
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/25/2024

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: GLM920060
• Device Lot Number: 30889359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2024
• Initial Report FDA Received Date: 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2022
• 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
• Patient Sex: Unknown