MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 6MM X 15CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLY120615
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 of a ruptured aneurysm for the va-pica bifurcation, a random loop of a galaxy g3 6mm x 15cm coil (gly120615, 30522186) was assumed and it was embolized, but the characteristics of the random loop was not able to be utilized.The procedure was acceptable embolization, and it completed safely.Aneurysm size of right va-pica bifurcation was 10*6.8*5.6.It was unclear if a continuous flush was done.Additional information received indicated that the coil was not noted to be unraveled/stretched.There was no damage reported to the microcatheter that could have caused the deployment difficulty.It is unknown the final position of the coil.The device was discarded; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device 30522186 number, and no non-conformances related to the malfunction were identified.Positioning difficulty-poor conformability is a potential complication associated with the use of this device.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¿.With the amount of information available and without the device for analysis, it is not possible to draw a conclusion between the device and the reported event.However, 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.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 of a ruptured aneurysm for the va-pica bifurcation, a random loop of a galaxy g3 6mm x 15cm coil (gly120615, 30522186) was assumed and it was embolized, but the characteristics of the random loop was not able to be utilized.The procedure was acceptable embolization, and it completed safely.Aneurysm size of right va-pica bifurcation was 10*6.8*5.6.It was unclear if a continuous flush was done.Additional information received indicated that the coil was not noted to be unraveled/stretched.There was no damage reported to the microcatheter that could have caused the deployment difficulty.It is unknown the final position of the coil.

• Brand Name: GALAXY G3 6MM X 15CM
• Common Device Name: 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 ; 9497898687
• MDR Report Key: 13169243
• Report Number: 3008114965-2022-00010
• Device Sequence Number: 5925687
• Product Code: KRD
• UDI-Device Identifier: 10886704077534
• UDI-Public: 10886704077534
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/05/2022

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
• Device Expiration Date: 01/31/2024
• Device Model Number: GLY120615
• Device Catalogue Number: GLY120615
• Device Lot Number: 30522186
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2021
• Initial Report FDA Received Date: 01/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED MICROCATHETER
• Patient Age: 75 YR
• Patient Sex: Female