MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 MINI 1MM X 1CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLM910010
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, ethnicity, and medical history 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.A review of manufacturing documentation associated with this lot (k10599) 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.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 the 1.00mm x 1.00cm galaxy g3 mini coil (glm910010 / k10599) was the second coil chosen to use in the procedure targeting a 2mm x 1.5mm aneurysm.The physician did not like the shape of the coil deployment and decided to remove the coil.During the resheathing attempt, the coil introducer failed to be re-zipped.Another 1.00mm x 1.00cm galaxy g3 mini coil was used and the procedure was successfully completed.There was no report of any patient adverse event or complication.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: pc-(b)(4).The purpose of this mdr submission is to report that the product analysis lab received the returned complaint device on 08/18/2020; the returned product underwent evaluation and analysis.[conclusion]: the healthcare professional reported that the 1.00mm x 1.00cm galaxy g3 mini coil (glm910010 / k10599) was the second coil chosen to use in the procedure targeting a 2mm x 1.5mm aneurysm.The physician did not like the shape of the coil deployment and decided to remove the coil.During the resheathing attempt, the coil introducer failed to be re-zipped.Another 1.00mm x 1.00cm galaxy g3 mini coil was used and the procedure was successfully completed.There was no report of any patient adverse event or complication.The product was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: the non-sterile 1.00mm x 1.00cm galaxy g3 mini coil was received contained in a pouch.Visual inspection was performed.The device positioning unit (dpu) was observed protruding from the introducer.The most likely cause of the dpu to protrude from the introducer is force.Force may have inadvertently been applied during procedural handling of the device.A microscopic inspection was performed.The marker band was found at 36.2cm from the distal end, this is within specification.The embolic coil was observed in good condition but was not adequately shaped.No other damage was observed on the device.A review of manufacturing documentation associated with this lot (k10599) 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 documented that during the procedure, the complaint coil was the second coil chosen to be used targeting a 2mm x 1.5mm aneurysm.However, the physician did not like the shape of the coil deployment and decided to remove the coil.During the resheathing attempt, the coil introducer failed to be re-zipped; this issue is confirmed based on the observation that the dpu of the device was protruding from the introducer.It was also observed under microscopic magnification that the embolic coil while without any observable damage, was not of adequate shape.This may have been the factor that contributed to the reported issue when the coil was deployed, the physician did not like the shape of the coil in the deployed state.Positioning difficulty / poor conformability is a known potential issue associated with the use of the device.Factors such as the shape of the target lesion, tortuosity of the parent vessel may have contributed to the way the coil is positioned and / or conforms when it gets delivered to the target site.Limited information is available related to the procedure and the reported device issues.Based on the review of the manufacturing documentation, 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.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 1MM X 1CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• MDR Report Key: 10404776
• Report Number: 3008114965-2020-00312
• Device Sequence Number: 14166685
• Product Code: KRD
• UDI-Device Identifier: 10886704080213
• UDI-Public: 10886704080213
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K171862
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2020

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: 01/31/2023
• Device Model Number: GLM910010
• Device Catalogue Number: GLM910010
• Device Lot Number: K10599
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2020
• Initial Date Received by Manufacturer: 07/27/2020
• Supplement Date Received by Manufacturer: 08/18/2020
• Initial Report FDA Received Date: 08/13/2020
• Supplement Report FDA Received Date: 09/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1