MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 XSFT 2.5MM X 3.5CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLX122535
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Date of event: the date of the event was not reported.Procode: krd/hcg.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.The images were reviewed by independent physician and the results are as follows.The imaging demonstrates a bifurcation aneurysm at various coiling stages, and it is unclear if a final image is presented as there is a microcatheter in all images.The aneurysm appears to be a distal aca aneurysm; however, the orientation of the images and the magnification makes identifying the aneurysm location challenging.I do not appreciate any coil herniation in the imaging or other issues related to the procedure.This is one of two products involved with the complaint and the associated manufacturer report numbers are 3008114965-2020-00300.
Event or Problem Description
As reported by the field, the delivery system of a 2.5mm x 5cm galaxy g3 xsft (glx122505, l15293) and a 2.5mm x 3.5cm galaxy g3 xsft (glx122535, l13110) is causing some concerns, the coils do not fill the aneurysm as well as the user was hoping.It is difficult to position them; they are either protruding into a vessel or they are difficult to be fully advanced.The user reported that sometimes they cannot advance a coil fully and it¿s not due to sizing, perhaps it is indeed due to the delivery system.The catheter kick back is very concerning.The system, especially the delivery wire feels very stiff.It¿s requiring some manipulation.Deployment of coils takes too long, as they are not easy to handle, which presents a risk of clot forming.There was no patient injury reported.Imaging was provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: as reported by the field, the delivery system of a 2.5mm x 5cm galaxy g3 xsft (glx122505, l15293) and a 2.5mm x 3.5cm galaxy g3 xsft (glx122535, l13110) is causing some concerns, the coils do not fill the aneurysm as well as the user was hoping.It is difficult to position them; they are either protruding into a vessel or they are difficult to be fully advanced.The user reported that sometimes they cannot advance a coil fully and it¿s not due to sizing, perhaps it is indeed due to the delivery system.The catheter kick back is very concerning.The system, especially the delivery wire feels very stiff.It¿s requiring some manipulation.Deployment of coils takes too long, as they are not easy to handle, which presents a risk of clot forming.There was no patient injury reported.Imaging was provided.The device was not returned for analysis.The images provided demonstrated a bifurcation aneurysm at various coiling stages, and it is unclear if a final image is presented as there is a microcatheter in all images.The aneurysm appears to be a distal aca aneurysm; however, the orientation of the images and the magnification makes identifying the aneurysm location challenging.There is no appreciation of coil herniation in the imaging or other issues related to the procedure.A manufacturing record evaluation was performed for the finished device l13110 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-coil herniation 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.Based on the limited information provided, it is possible that clinical and procedural factors, including device manipulation / interaction, aneurysm size and vessel characteristics, device selection, and the concomitant microcatheter, may have contributed to the reported issue.The 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¿.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.

• Brand Name: GALAXY G3 XSFT 2.5MM X 3.5CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• MDR Report Key: 10332249
• Report Number: 3008114965-2020-00301
• Device Sequence Number: 3209708
• Product Code: KRD
• UDI-Device Identifier: 10886704077619
• UDI-Public: 10886704077619
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2020

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: GLX122535
• Device Catalogue Number: GLX122535
• Device Lot Number: L13110
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/06/2020
• Supplement Date Received by Manufacturer: 07/29/2020
• Initial Report FDA Received Date: 07/28/2020
• Supplement Report FDA Received Date: 08/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GALAXY G3 XSFT 2.5MM X 5CM