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

Catalog Number GLM920060

Device Problem Failure to Advance (2524)

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

Event Date 09/19/2023

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).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 initial reporter phone: (b)(6).The complaint device was returned for evaluation and analysis.The investigation finding is documented below.Investigation summary: a non-sterile 2.00mm x 6.00cm galaxy g3 mini was received contained in the decontamination pouch.Visual inspection was performed.It was noted that the coil was inside the introducer.The core wire was observed kinked and protruding from the introducer.The embolic coil component was inspected under the microscope.It was observed kinked and to still be attached to the resistance heating (rh) coil and is still in one piece.The rh coil was not softened, an indication that the detachment process had not been initiated.A dimensional analysis was performed and the inner diameter (id) of the distal introducer was confirmed to be within specification.The issue regarding a coil being unable to advance was confirmed since the damages noted in the coil and the core wire prevented the ability to move the coil.Coil kinking is a known potential issue associated with the use of this device.The instructions for use (ifu) provide proper handling instructions for the device to prevent such issues from occurring.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 kinking.The damage observed in the coil 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.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 (30830571) 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.Devices undergo 100% inspection at final assembly for coil condition to prevent coil damage from leaving the facility.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.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.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.

Event Description

The healthcare professional reported that during coil embolization of an internal carotid artery (ica) aneurysm, the 2.00mm x 6.00cm galaxy g3 mini (glm920060 / 30830571) was used in accordance with the instruction for use (ifu).After using a competitor coil for framing, the 2.00mm x 6.00cm galaxy g3 mini was planned to be implanted toward the end of the filling.The 2.00mm x 6.00cm galaxy g3 mini was inserted into the goodtec y- connector (goodman), and the introducer was advanced up to the concomitant phenom¿ microcatheter (medtronic).Then an attempt was made to deliver the 2.00mm x 6.00cm galaxy g3 mini, but it could not be delivered.An attempt to push the coil out of the introducer outside of the patient, but it was also difficult.The microcatheter was not removed nor replaced.Continuous flush was reportedly not maintained.Additional information received on (b)(6) 2023 indicated that the tip of the introducer was firmly installed into the hub of the microcatheter and locked with the rotating hemostasis valve (rhv) during the advancement of the device.Excessive force had not been applied to the device.The coil was replaced with another galaxy g3 mini and the procedure was successfully completed.There was no negative impact to the patient.The 2.00mm x 6.00cm galaxy g3 mini was returned for evaluation and analysis.Based on the result of the product analysis completed on (b)(6) 2023 the reported issue meets usfda reporting criteria under 21 cfr 803 as a "malfunction.".

• Brand Name: GALAXY G3 MINI 2MM X 6CM
• 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: 18341059
• MDR Text Key: 331054471
• Report Number: 3008114965-2023-00961
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 10886704080312
• UDI-Public: 10886704080312
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Physician
• Type of Report: Initial
• Report Date: 12/15/2023

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: GLM920060
• Device Lot Number: 30830571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2023
• Initial Date FDA Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2022
• 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
• Treatment: GOODTEC Y- CONNECTOR (GOODMAN); PHENOM¿ MICROCATHETER (MEDTRONIC)