MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 MINI 2.5MM X 4.5CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLM925045
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).Regarding patient weight, height, medical history, race, and ethnicity was not reported.Procode: krd/hcg.Initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.The product is not available for evaluation and testing.Additional information will be submitted within 30 days of receipt.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Based on the photo provided, it can determine that the embolic coil of the device has a knotted condition.Only the distal part of the device was shown on the pictures.No other damages could be observed.A manufacturing record evaluation was performed for the finished device 30356229 number, and no non-conformances related to the reported complaint condition were identified.The reported condition ¿coil -kinked/bent-knotted/in patient¿ was confirmed since the embolic coil could be appreciated knotted, however the exact time when this condition occur could not conclusively determined.The reported condition ¿detachable coil delivery system (dcs) -kinked/bent- impeded with no loss of cerebral target position¿ could not be evaluated based on the picture received.
Event or Problem Description
As reported by the field, during a coil embolization, there was no movement in the excelsior10 microcatheter (mc), the 2.5mm x 4.5cm galaxy g3 mini coil (glm925045, 30356229) was tied.There was no patient injury reported.Pictures were 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.Section b5:additional information received indicated that the procedure was completed by using another coil.Complaint conclusion: as reported by the field, during a coil embolization, there was no movement in the excelsior10 microcatheter (mc), the 2.5mm x 4.5cm galaxy g3 mini coil (glm925045, 30356229) was tied.There was no patient injury reported.Pictures were provided.Additional information received indicated that the procedure was completed by using another coil.The device was not returned for analysis.Based on the photo provided, it was determined that the embolic coil of the device has a knotted condition.Only the distal part of the device was shown on the pictures.No other damages could be observed.A manufacturing record evaluation was performed for the finished device 30356229 number, and no non-conformances related to the reported complaint condition were identified.The reported condition ¿coil -kinked/bent-knotted/in patient¿ was confirmed since the embolic coil could be appreciated knotted, however the exact time when this condition occur could not conclusively determined.The reported condition ¿detachable coil delivery system (dcs) -kinked/bent- impeded with no loss of cerebral target position¿ could not be evaluated based on the picture received.Per the instructions for use (ifu), if the operator encounters kinking or damage during clinical use, they are clinically trained to immediately discontinue manipulations and remove the product.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, vessel characteristics, device selection, and the concomitant microcatheter, may have contributed to the reported issue.Kinking can be caused by the application of excessive force to a device while trying to advance against resistance.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 2.5MM X 4.5CM
• 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: 10232607
• Report Number: 3008114965-2020-00264
• Device Sequence Number: 2228591
• Product Code: KRD
• UDI-Device Identifier: 10886704080275
• UDI-Public: 10886704080275
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 06/18/2020

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: 01/31/2023
• Device Model Number: GLM925045
• Device Catalogue Number: GLM925045
• Device Lot Number: 30356229
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/18/2020
• Supplement Date Received by Manufacturer: 07/10/2020
• Initial Report FDA Received Date: 07/06/2020
• Supplement Report FDA Received Date: 07/29/2020
• 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: EXCELSIOR10 MICROCATHETER