MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 6MM X 20CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLY120620
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).Patient identifier: (b)(6).Procode: krd/hcg.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: as reported via the sterling registry, during the coil embolization to the right internal carotid artery (anterior circulation), there was positioning difficulties with a 6mm x 20cm galaxy g3 coil (gly120620, l13267).There was no device-related serious adverse event.Per the study investigator, the device did not ¿work so well¿ because the unspecified micro catheter (mc) would herniate outside of the aneurysm into the parent vessel when deploying the very last segment of the coil.The initial stages were fine.This necessitated repeated catheterization of the aneurysm dome with the microcatheter at deeper and deeper levels just to keep the coil within the aneurysm and this still didn¿t work.It was decided not to continue with coil embolization because the coil was not stable and ended up concluding the procedure with a flow diversion (pulserider).The side wall unruptured aneurysm had a parent vessel diameter of 3.8mm, height 9.2mm and dome 7.8mm.Maximum aneurysm diameter was 9.2mm, neck size 7.3mm and dome to neck ration of 1.1mm.The device has been discarded; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device l13267 number, and no non-conformances related to the reported complaint condition were identified.With the information available and without the product available for analysis, the reported customer complaint of ¿coil - positioning difficulty¿ could not be confirmed.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.The instructions for use (ifu) instructs on proper positioning of the microcoil system.The ifu also warns: ¿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¿.The exact cause of the event could not be determined; however, there are circumstances of the procedure that may have contributed to the reported failure.It is possible that clinical and procedural factors, including device manipulation / interaction, aneurysm size/vessel characteristics (i.E.Wide neck of the aneurysm), device selection, and the concomitant microcatheter, may have contributed to the reported issue.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.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.
Event or Problem Description
As reported via the sterling registry, during the coil embolization to the right internal carotid artery (anterior circulation), there was positioning difficulties with a 6mm x 20cm galaxy g3 coil (gly120620, l13267).There was no device-related serious adverse event.Per the study investigator, the device did not ¿work so well¿ because the unspecified micro catheter (mc) would herniate outside of the aneurysm into the parent vessel when deploying the very last segment of the coil.The initial stages were fine.This necessitated repeated catheterization of the aneurysm dome with the microcatheter at deeper and deeper levels just to keep the coil within the aneurysm and this still didn¿t work.It was decided not to continue with coil embolization because the coil was not stable and ended up concluding the procedure with a flow diversion (pulserider).The side wall unruptured aneurysm had a parent vessel diameter of 3.8mm, height 9.2mm and dome 7.8mm.Maximum aneurysm diameter was 9.2mm, neck size 7.3mm and dome to neck ration of 1.1mm.

• Brand Name: GALAXY G3 6MM X 20CM
• 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: 9750934
• Report Number: 3008114965-2020-00032
• Device Sequence Number: 11530271
• Product Code: KRD
• UDI-Device Identifier: 10886704077541
• UDI-Public: 10886704077541
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/04/2020

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: 06/30/2021
• Device Model Number: GLY120620
• Device Catalogue Number: GLY120620
• Device Lot Number: L13267
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2020
• Initial Report FDA Received Date: 02/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Weight: 87