MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 XSFT 2.5MM X 3.5CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	GLX122535
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/30/2019
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.Manufacturing site name: codman and shurtleff inc., dba depuy synthes products, inc.(b)(4).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 a healthcare professional, during a coil embolization of an aneurysm at aca, during advancement through a rester microcatheter (mc), there was resistance with a 2.5mm x 3.5cm galaxy g3 xsft coil (glx122535, l13257).The complaint coil was used as the first coil.The physician attempted to pull out the coil delivery system, but it prematurely detached.The complaint coil was removed with the mc and a competitive coil was used to complete the procedure.There was no additional intervention required to remove the coil.There was no clinically significant prolongation in the procedure due to the event.The devices were prepped per the instructions for use (ifu).No damages were confirmed prior to use.Adequate flush had been maintained through the devices.No excessive force had been applied to the device.
Additional Manufacturer Narrative
Product complaint # (b)(4).Complaint conclusion: as reported by a healthcare professional, during a coil embolization of an aneurysm at aca, during advancement through a rester microcatheter (mc), there was resistance with a 2.5mm x 3.5cm galaxy g3 xsft coil (glx122535, l13257).The complaint coil was used as the first coil.The physician attempted to pull out the coil delivery system, but it prematurely detached.The complaint coil was removed with the mc and a competitive coil was used to complete the procedure.There was no additional intervention required to remove the coil.There was no clinically significant prolongation in the procedure due to the event.The devices were prepped per the instructions for use (ifu).No damages were confirmed prior to use.Adequate flush had been maintained through the devices.No excessive force had been used with the device.The device was discarded; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device l13257 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 ¿coil premature ¿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.Assignment of root cause for the event remains speculative and inconclusive, based on the information provided and without the return of the complaint devices; 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 XSFT 2.5MM X 3.5CM
• 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: 9224004
• Report Number: 3008114965-2019-01211
• Device Sequence Number: 19316395
• Product Code: KRD
• UDI-Device Identifier: 10886704077619
• UDI-Public: 10886704077619
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K150319
• 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): 10/01/2019

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: 06/30/2021
• Device Catalogue Number: GLX122535
• Device Lot Number: L13257
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 10/23/2019
• Initial Report FDA Received Date: 10/23/2019
• Supplement Report FDA Received Date: 11/06/2019
• 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: RESTER MICROCATHETER.