MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 MINI 1.5MM X 2.5CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLM915025
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/15/2020
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, 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).The company is seeking this information through the event investigation.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.The device was discarded; therefore, no additional investigation can be performed.A manufacturing record evaluation was performed for the finished device l14363 number, and no non-conformance's related to the reported complaint condition were identified.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
As reported by the field, during an emergent coil embolization for subarachnoid hemorrhage (sah), a 1.5mm x 2.5cm galaxy g3 mini coil (glm915025, l14363) was used as the eighth coil but there was an intensive resistance felt when it advanced through an unspecified concomitant microcatheter (mc).They were removed from the patient and the microcatheter was flushed.The physician tried again but the same issue continued.The complaint coil was replaced with another same sized coil and the procedure completed.The customer states there is no additional information available.
Additional Manufacturer Narrative
Product complaint #(b)(4).Updated sections on this medwatch report: b5, g4, g7, h2 and h10.Section b5: additional information received indicated that the same mc was used to complete the procedure.There were no procedure delays due to the event.The lesion was the tip of the vertebral artery (va).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 an emergent coil embolization for subarachnoid hemorrhage (sah), a 1.5mm x 2.5cm galaxy g3 mini coil (glm915025, l14363) was used as the eighth coil but there was an intensive resistance felt when it advanced through an unspecified concomitant microcatheter (mc).They were removed from the patient and the microcatheter was flushed.The physician tried again but the same issue continued.The complaint coil was replaced with another same sized coil and the procedure completed.Additional information received indicated that the same mc was used to complete the procedure.There were no procedure delays due to the event.The lesion was the tip of the vertebral artery (va).The device was discarded; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device l14363 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 ¿detachable coil delivery system (dcs) - resistance/friction-during advancement with loss of cerebral target position¿ 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) caution that if unusual friction is still noticed during advancement or retraction of the coil system, verify flush lines are open and properly pressurized.Then slowly withdraw the entire catheter system and examine for damage.Replace it with a new system.If friction still exists, withdraw and examine the delivery catheter system.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 1.5MM X 2.5CM
• 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: 10507452
• Report Number: 3008114965-2020-00404
• Device Sequence Number: 3344545
• Product Code: KRD
• UDI-Device Identifier: 10886704080121
• UDI-Public: 10886704080121
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K171862
• 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): 08/17/2020

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: 11/30/2021
• Device Model Number: GLM915025
• Device Catalogue Number: GLM915025
• Device Lot Number: L14363
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/17/2020
• Supplement Date Received by Manufacturer: 10/01/2020
• Initial Report FDA Received Date: 09/09/2020
• Supplement Report FDA Received Date: 10/22/2020
• 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: UNSPECIFIED MICROCATHETER.