MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 MINI 1.5MM X 3CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	GLM915030
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The healthcare professional reported that prior to an endovascular embolization procedure, the coil, a 1.50mm x 3.00cm galaxy g3 mini (glm915030 / 30889332) was meant to be inspected in sodium chloride solution, but there was resistance when the coil was being pushed out of the introducer sheath.The coil failed to exit the introducer sheath.On 10-apr-2024, additional information was received.Per the information, there was nothing noted to be obstructing the introducer.Continuous flush was maintained.The introducer was flushed until liquid was visible at the distal end of the slit in the clear tube.Excessive force had not been applied to the device.The complaint device was returned for evaluation and analysis.Based on the result of the product analysis completed on 27-jun-2024, the reported issue meets usfda reporting criteria under 21 cfr 803 as a "malfunction.".
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 and email address are not available / reported.The complaint device was returned for evaluation and analysis.The investigation finding is documented below.Investigation summary: a non-sterile 1.50mm x 3.00cm galaxy g3 mini was received contained in the decontamination pouch.Visual inspection was performed.It was noted that the core wire was kinked and protruding from the introducer.The coil component was inspected under the microscope.It was observed slightly stretched with multiple kinks noted on it, the coil was also observed still attached to the resistance heating (rh) coil and is still in one piece.The rh coil was observed not softened, indicating that the detachment process had not been initiated.A dimensional analysis was performed.The distal inner diameter (id) of the 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 and stretching are known potential issues 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.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 and stretching.The damages observed in the coil were 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 (30889332) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.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.

• Brand Name: GALAXY G3 MINI 1.5MM X 3CM
• 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: 19626150
• Report Number: 3008114965-2024-00643
• Device Sequence Number: 15061476
• Product Code: KRD
• UDI-Device Identifier: 10886704080145
• UDI-Public: 10886704080145
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 06/27/2024

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: GLM915030
• Device Lot Number: 30889332
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2024
• Initial Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2022
• 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