MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 MINI 2.5MM X 5.5CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	GLM925055
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2024
Type of Reportable Event	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 is not available / reported.The complaint device was returned for evaluation and analysis.The investigation finding is documented below.Investigation summary: a non-sterile 2.5mm x 5.5cm galaxy g3 mini was received contained in the decontamination pouch.Visual inspection was performed.It was observed that the embolic coil was returned still inside the introducer.Microscopic inspection was performed.Under magnification, the tip of the embolic coil was observed protruding from the introducer due to a slit.The rest of the embolic coil was observed to be in severely stretched condition and as a result of the stretching, the internal blue fiber was exposed.The embolic coil was observed still attached to the resistance heating (rh) coil, which was noted as not softened.No other damages were observed.The issue documented in the complaint that the coil that was impeded at the proximal end of the microcatheter was confirmed based on the appearance of the returned device.The damaged condition of the introducer was not originally reported; however, this could be the result of the difficulty experienced during the procedure that could not be replicated in the laboratory.The stretched damage observed in the coil was 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 stretching.Coil stretching 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.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 (30803121) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.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.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 or Problem Description
The healthcare professional reported that during an endovascular embolization procedure, the concomitant microcatheter (competitor brand) was in place and three coils were used to fill the aneurysm, then the fourth coil, a 2.5mm x 5.5cm galaxy g3 mini (glm925055 / 30803121) was used, it was impeded in the proximal end of the microcatheter and could not be further advanced.The physician retracted the coil and replaced it to complete the procedure using the same microcatheter.There was no report of any negative patient impact.On 16-jul-2024, additional information was received.Per the information, the target vessel was the left internal carotid artery (ica).Nothing was noted to be obstructing the microcatheter.The issue related to the coil becoming impeded ¿occurred during import.¿ a continuous flush had been maintained through the microcatheter.The introducer tip was firmly installed into the microcatheter hub and locked with the rotating hemostasis valve (rhv) during the advancement of the device.Per the information, there was no delay in the procedure as a result of the reported issue.The complaint device was returned for evaluation and analysis.Based on the result of the product analysis completed on 07-aug-2024, the reported issue meets usfda reporting criteria under 21 cfr 803 as a "malfunction.".

• Brand Name: GALAXY G3 MINI 2.5MM X 5.5CM
• 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: 19933285
• Report Number: 3008114965-2024-00784
• Device Sequence Number: 20891618
• Product Code: KRD
• UDI-Device Identifier: 10886704080282
• UDI-Public: (01)10886704080282(11)220518(17)250430(10)30803121
• 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
• Report Date (Section B): 08/07/2024

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: 04/30/2025
• Device Catalogue Number: GLM925055
• Device Lot Number: 30803121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2024
• Initial Report FDA Received Date: 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2022
• 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