MAUDE Adverse Event Report: GALAXY G3 XSFT 3.5MM X 5CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	GLX123505
Medical Device Problem Codes	Difficult To Position (1467); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Continued from manufacturer name: codman and shurtleff inc., dba depuy synthes products, inc.((b)(4)).Information regarding age, weight, gender and medical history were not available.Conclusion: the galaxy products were not returned for investigation.A review of manufacturing documentation associated with these lots presented no issues during the manufacturing or inspection processes related to the reported complaint.The positioning difficulty and coil stretch could not be confirmed without product return for analysis.The root cause of the events could not be determined; however, the multiple positioning may have been a factor associated with the coil stretch.Procedure and aneurysm factors may have contributed to the positioning difficulty.There is no current safety signal identified related to the reported events based on reviews of complaint histories for the devices.Since there was no evidence to suggest the event was related to a manufacturing issue, no corrective actions will be taken at this time.This is an initial/final mdr report.
Event or Problem Description
As reported by a healthcare professional, during left pericallosal coil embolization, three galaxy g2 coils (gly120615 / s11513, glx120408/ s12259, glx123505/ s11634) were advanced into the aneurysm until there was approximately 1-1.5cm left of the length to insert into aneurysm.At this point, each of these coils failed to break and remained straight resulting in protrusion back into the phenom 17 with 45-degree tip microcatheter and microcatheter push-back.In addition, the first coil (gly120615 / s11513) stretched.The physician retracted and re-attempted each coil multiple times which had the same result each time of failure to break at the 1-1.5cm point.Each coil was removed from the patient and was discarded.The microcatheter did not appear damaged and devices had been prepped and used as per the ifu.There was not patient injury and the event delayed the procedure 10 minutes.Information regarding patient age, gender, weight and medical history were not available.

• Brand Name: GALAXY G3 XSFT 3.5MM X 5CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• MDR Report Key: 7109867
• Report Number: 3008114965-2017-00508
• Device Sequence Number: 19154987
• Product Code: KRD
• UDI-Device Identifier: 10886704077657
• UDI-Public: (01)10886704077657(17)190731(10)S11634
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/17/2017

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: 07/31/2019
• Device Catalogue Number: GLX123505
• Device Lot Number: S11634
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/17/2017
• Initial Report FDA Received Date: 12/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1