MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 MINI 1MM X 1.5CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLM910015
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/19/2020
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: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.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 product is not available for evaluation and testing.Additional information will be submitted within 30 days of receipt.Based on the photo provided, there are no apparent damage that could be appreciate on the picture.Only the label was shown.A manufacturing record evaluation was performed for the finished device l16005 number, and no non-conformances related to the reported complaint condition were identified.The reported condition ¿coil -kinked/bent-knotted/in patient¿ could not be evaluated based on the picture received.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 1mm x 1.5cm galaxy g3 mini coil (glm910015, l16005).There was no patient injury reported.A picture was 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 further indicated that the coil was ¿knotted¿.The procedure was completed by using another coil of the same size.Other products were successfully used with the concomitant device after the issue.Complaint conclusion: as reported by the field, during a coil embolization, there was no movement in the excelsior10 microcatheter (mc), the 1mm x 1.5cm galaxy g3 mini coil (glm910015, l16005).There was no patient injury reported.A picture was provided.Additional information received further indicated that the coil was ¿knotted¿.The procedure was completed by using another coil of the same size.Other products were successfully used with the concomitant device after the issue.The device was not returned for analysis.Based on the photo provided, there is no apparent damage could be appreciated.Only the label was shown.A manufacturing record evaluation was performed for the finished device l16005 number, and no non-conformances related to the reported complaint condition were identified.The reported condition ¿coil -kinked/bent-knotted/in patient¿ could not be evaluated based on the picture received.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.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 1MM X 1.5CM
• 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: 10232702
• Report Number: 3008114965-2020-00265
• Device Sequence Number: 14010297
• Product Code: KRD
• UDI-Device Identifier: 10886704080206
• UDI-Public: 10886704080206
• Combination Product (Y/N): N
• PMA/510(K) Number: K171862
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2020

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: 05/31/2022
• Device Model Number: GLM910015
• Device Catalogue Number: GLM910015
• Device Lot Number: L16005
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/19/2020
• 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