MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 MINI 2MM X 3CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLM920030
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (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.
Event or Problem Description
As reported by the field, during a coil embolization of the internal carotid, a galaxy g3 mini coil 2mm x 3cm (glm920030, 30558131) was being used as a second coil.It was inserted and advanced without any problems, but it was unable to be detached.The detachment button of a cable was pressed sixth times, but the complaint coil was unable to be detached.It was replaced with another coil.Additional information received indicated that a pre-deployment electrical testing was performed.The same dcb was used successfully with subsequent coils and the same cable was used successfully with subsequent coils.The coil was not stretched or damaged when removed from the patient.The event did not prolong the procedure.
Additional Manufacturer Narrative
Product complaint # (b)(4).Updated sections on this medwatch report: b4, g3, g6, h2, h6 and h10.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 the internal carotid, a galaxy g3 mini coil 2mm x 3cm (glm920030, 30558131) was being used as a second coil.It was inserted and advanced without any problems, but it was unable to be detached.The detachment button of a cable was pressed sixth times, but the complaint coil was unable to be detached.It was replaced with another coil.Additional information received indicated that a pre-deployment electrical testing was performed.The same dcb was used successfully with subsequent coils and the same cable was used successfully with subsequent coils.The coil was not stretched or damaged when removed from the patient.The event did not prolong the procedure.The device was discarded; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device 30558131 number, and no non-conformances related to the malfunction were identified.Failure to detach is a known potential issue associated with the use of this device.The instructions for use (ifu) contains several precautions related to this issue and includes instructions for troubleshooting the situation should it be encountered during use.With the information available and without the product available for analysis, the reported customer complaint could not be confirmed.Based on the manufacturing record evaluation (mre), there is no indication that the event is related to the device manufacturing process.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint device; 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.

• Brand Name: GALAXY G3 MINI 2MM X 3CM
• 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: 13281205
• Report Number: 3008114965-2022-00038
• Device Sequence Number: 4835577
• Product Code: KRD
• UDI-Device Identifier: 10886704080299
• UDI-Public: 10886704080299
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K171862
• 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,Followup
• Report Date (Section B): 02/07/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: GLM920030
• Device Catalogue Number: GLM920030
• Device Lot Number: 30558131
• 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: 12/29/2021
• Supplement Date Received by Manufacturer: 01/20/2021
• Initial Report FDA Received Date: 01/18/2022
• Supplement Report FDA Received Date: 02/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GALAXY G3 MINI 1.5MM X 3CM
• Patient Sex: Unknown