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

Model Number GLM920060

Device Problem Stretched (1601)

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

Event Date 12/14/2021

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.Procode is krd/hcg.The name, phone and email address of the initial reporter are not available / reported.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 photo of the complaint device was reviewed by the product analysis lab and is documented below.[photo analysis]: based on the photo included in the complaint, the embolic coil component of the 2.00mm x 6.00cm galaxy g3 mini is observed to be partially outside of the introducer.The regular coiled shape of the embolic coil was not present; however, no damages could be observed on the embolic coil component.A review of manufacturing documentation associated with this lot (30375968) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformance's related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.The complaint reported that the 2.00mm x 6.00cm galaxy g3 mini coil became stretched during the procedure.The reported issue could not be confirmed based on the photo, there was no damage was noted on the embolic coil based on the photo.The manufacturing record review was performed.Based on the review, the reported issue in the complaint is not related to the manufacturing process.Further investigation will be performed when the complaint device is returned for evaluation and analysis.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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 an endovascular embolization procedure, the 2.00mm x 6.00cm galaxy g3 mini coil (glm920060 / 30375968) became stretched during the procedure.There was no report of any patient adverse event or complication.A photo of the complaint device was included in the complaint file.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product was received by cerenovus product analysis lab on 22-feb-2022.The return product is pending evaluation.A supplemental 3500a report will be submitted once the product investigation has been completed.Updated sections: b.4, d.9, g.3, g.6.H.2, h.3, h.6, and h.10.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 investigational finding of the returned device.[conclusion]: the healthcare professional reported that during an endovascular embolization procedure, the 2.00mm x 6.00cm galaxy g3 mini coil (glm920060 / 30375968) became stretched during the procedure.There was no report of any patient adverse event or complication.A photo of the complaint device was included in the complaint file.Multiple attempts to obtain additional information related to the procedure and the reported device issue were unsuccessful.If additional information is received at a later date, this file will be updated accordingly.A photo of the complaint device was included in the complaint file.The photo of the complaint device was reviewed by the product analysis lab and is documented below.[photo analysis]: based on the photo included in the complaint, the embolic coil component of the 2.00mm x 6.00cm galaxy g3 mini is observed to be partially outside of the introducer.The regular coiled shape of the embolic coil was not present; however, no damages could be observed on the embolic coil component.A review of manufacturing documentation associated with this lot (30375968) 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.The complaint reported that the 2.00mm x 6.00cm galaxy g3 mini coil became stretched during the procedure.The reported issue could not be confirmed based on the photo, there was no damage was noted on the embolic coil based on the photo.The manufacturing record review was performed.Based on the review, the reported issue in the complaint is not related to the manufacturing process.The complaint device was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: a non-sterile 2.00mm x 6.00cm galaxy g3 mini coil was received contained in a pouch.Visual inspection was performed.The core wire was noted to be kinked at 72.5 inches from the proximal end.The introducer showed evidence of use as it was peeled and the zipper was not reaching the most proximal end.This is an indication that the introducer had been un-zipped to advance the embolic coil out.Microscopic inspection was performed.The embolic coil component is observed in good condition.No elongations, kinks, or non-concentric loops were observed.The observations made during the visual and microscopic inspection of the returned device is consistent with the photo of the complaint device.The embolic coil is noted to be in good condition without any damages such as elongation, kink, or with non-concentric loops.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.The complaint documented that the 2.00mm x 6.00cm galaxy g3 mini coil became stretched during the procedure.The complaint device was returned and there is no indication of the coil in stretched condition.The embolic coil was without any elongations, kinks, or non-concentric loops.Based on the visual and microscopic inspection performed on the returned device, the reported issue was not confirmed.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.There may have been other circumstances or issues that occurred during the procedure when the device was in use that are not provided in the subsequent follow-up for additional information related to the procedure and the reported device issue.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 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): CODMAN & SHURTLEFF, INC. (FREMONT); 47709 fremont blvd; fremont CA 94538
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 949789-868
• MDR Report Key: 13102061
• MDR Text Key: 290544382
• Report Number: 3008114965-2021-00667
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 10886704080312
• UDI-Public: 10886704080312
• 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: 03/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: GLM920060
• Device Catalogue Number: GLM920060
• Device Lot Number: 30375968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2020
• 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