MAUDE Adverse Event Report: GALAXY G3 9MM X 25CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	GLY120925
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) this initial/final mdr will be the only report submitted for mfr report #3008114965-2018-00512.Procode: krd/hcg.(b)(4).Conclusion: the device was returned with its inner pouch.Labeling on the inner pouch matches the product documented in the complaint.The embolic coil has been advanced out of the introducer.The device positioning unit (dpu) core wire protrudes from the skive of the translucent introducer sheath.There are slight bends in the dpu core wire approximately 57 cm and 61 cm from the proximal end.The ball tip is intact.The embolic coil is kinked.The articulating joint is intact.The resistance heating (rh) coil has not received heat.The v-notch of the resheathing tool is undamaged.Since the dpu core wire protrudes from the skive of the translucent introducer sheath distally to the resheathing tool, the device cannot be resheathed.A review of manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.The complaint that there is difficulty rezipping the introducer is confirmed.Since the dpu core wire protrudes from the skive of the translucent introducer sheath distally to the resheathing tool, it is not possible to re-form the introducer around the core wire.The kinked embolic coil and bends in the dpu core wire suggest that excessive force was applied to the device.The details and sequence of events surrounding the reported issue are not known, so the cause for application of force cannot be identified.There is no current safety signal identified related to the reported event based on review of complaint history for the device.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.
Event or Problem Description
It was reported by a healthcare professional that two galaxy g3 coils (gly120925/s11884 and gly120410/s11711) were used during a procedure and the coils could not be re-sheathed.Note: this event was deemed reportable based on the device evaluation results.

• Brand Name: GALAXY G3 9MM X 25CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• MDR Report Key: 7244802
• Report Number: 3008114965-2018-00512
• Device Sequence Number: 13714123
• Product Code: KRD
• UDI-Device Identifier: 10886704077596
• UDI-Public: (01)10886704077596(17)190831(10)S11884
• Combination Product (Y/N): N
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 11/08/2017

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: 08/31/2019
• Device Catalogue Number: GLY120925
• Device Lot Number: S11884
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2017
• Initial Date Received by Manufacturer: 11/08/2017
• Initial Report FDA Received Date: 02/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1