MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 XSFT 3MM X 4CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLX120304
Medical Device Problem Codes	Mechanical Problem (1384); Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).The purpose of this mdr submission is to report the findings of the device investigation.The embolic coil was noted to being stretched and mechanically detached, meeting regulatory reporting criteria.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Procode: krd/hcg.Initial reporter phone: (b)(6).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, during a coil embolization, a 3mm x 4cm galaxy g3 xsft coil (glx120304, l14009) was attempted to be re-sheathed to change the size.However, the sheath introducer got split and it was not able to be re-sheathed.It was replaced with another coil and the procedure was completed.The customer states there is no additional information available.Based on the analysis of the device received, the embolic coil was found stretched and mechanically detached.One non-sterile unit galaxy g3 xsft 3mm x 4cm was received inside of a pouch.The received device was visually inspected.The introducer was found damaged and separated from the unit.Then a microscopic analysis was performed, and the embolic coil was found stretched and mechanically detached.No other damages were observed.Also, the marker band was found at 39cm from distal end and it was found within specification.A manufacturing record evaluation was performed for the finished device l14009 number, and no non-conformances related to the reported complaint condition were identified the complaint reported by the customer ¿coil introducer ¿ zipping difficulty-rezipping¿ was confirmed.Although the introducer was found separated from the unit, the introducer was found damaged and due to this observation, the event was confirmed.The complaint reported by the customer ¿coil introducer ¿ premature peeling¿ was confirmed, although this could not be evaluated due to the conditions of the received device (introducer separated).The damaged condition noted on the introducer may contribute to this failure and due to this we can confirm the event.The damaged and stretched condition appears to have been caused by excessive force.Neither the analysis nor the mre suggests that the failure reported could be related to the manufacturing process.The instructions for use (ifu) instructs the user to unsheathe a small length of the dpu to unlock the device, then to advance the embolic coil into the microcatheter until the hub connector of the dpu reaches the proximal end of the resheathing tool.This results in the placement of the embolic coil and the more flexible and fragile distal sections of the dpu inside the microcatheter before continuing to unsheathe the device.If the device is unsheathed before advancing into the microcatheter, there is a risk that the embolic coil or the distal end of the dpu will be unsheathed and pass through the resheathing tool.If the resheathing tool passes over the distal end of the dpu, this will expose these flexible sections, which will then be subject to kinking and bending.Once a part of the dpu is kinked or bent, the translucent introducer sheath will not be able to re-form around it, and that section of the device will protrude.Assignment of root cause for the events remains speculative and inconclusive, based on the limited information provided and the evidence presented by the returned device; however, it is possible that clinical and procedural factors, including device manipulation and device interaction, may have contributed to the reported failures and damages on the returned 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.
Event or Problem Description
As reported by the field, during a coil embolization, a 3mm x 4cm galaxy g3 xsft coil (glx120304, l14009) was attempted to be re-sheathed to change the size.However, the sheath introducer got split and it was not able to be re-sheathed.It was replaced with another coil and the procedure was completed.The customer states there is no additional information available.Based on the analysis of the device received, the embolic coil was found stretched and mechanically detached.

• Brand Name: GALAXY G3 XSFT 3MM X 4CM
• 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: 10127994
• Report Number: 3008114965-2020-00232
• Device Sequence Number: 13976767
• Product Code: KRD
• UDI-Device Identifier: 10886704077688
• UDI-Public: 10886704077688
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 03/15/2020

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: 09/30/2021
• Device Model Number: GLX120304
• Device Catalogue Number: GLX120304
• Device Lot Number: L14009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/02/2020
• Initial Report FDA Received Date: 06/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1