MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 MINI 2.50MM X 5.50CM; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Catalog Number	GLM925055
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #(b)(4).Complaint conclusion: as reported by a health care professional, during a coil embolization to a 4mm aneurysm of the posterior communicating artery (pcon), once an orbit galaxy g3 mini microcoil ((b)(4)) was detached, a tail fell into the parent vessel.There was no patient injury reported.The surgery was not delayed due to the event.No additional intervention was provided.The device was stored, inspected and prepped per instructions for use (ifu).No anomalies were noted prior to use.No excessive force was used at any time during the use of the device.There were no difficulties detaching the device.There were no attempts to remove coil.The coil was not fixed to the vessel wall by stent, obstruction of flow, thrombosis.No stent was not used.The orbit galaxy was the first and only coil used in this procedure.The microcatheter was seeded 1/3 of the way in the aneurysm at the time of detachment.The galaxy g3 mini product was not returned for investigation.A review of manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection processes related to the reported complaint.With the information available and without the product available for analysis, the reported customer complaint 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.The exact cause of the event could not be determined; however, clinical and procedural factors including vessel characteristics, device selection, and the concomitant microcatheter may have contributed to the reported failure.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.Protocode should be krd/hcg.Physical manufacturer: codman and shurtleff inc., dba depuy synthes products, inc.((b)(4)) information regarding patient age, gender, weight, race, ethnicity, and medical history were not provided.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 manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
As reported by a health care professional, during a coil embolization to a 4mm aneurysm of the posterior communicating artery (pcon), once an orbit galaxy g3 mini microcoil ((b)(4)) was detached, a tail fell into the parent vessel.There was no patient injury reported.The surgery was not delayed due to the event.No additional intervention was provided.The device will not be returned for investigation as it was implanted.The device was stored, inspected and prepped per instructions for use (ifu).No anomalies were noted prior to use.No excessive force was used at any time during the use of the device.There were no difficulties detaching the device.There were no attempts to remove coil.The coil was not fixed to the vessel wall by stent, obstruction of flow, thrombosis.No stent was not used.The orbit galaxy was the first and only coil used in this procedure.The microcatheter was seeded 1/3 of the way in the aneurysm at the time of detachment.

• Brand Name: GALAXY G3 MINI 2.50MM X 5.50CM
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• MDR Report Key: 7336221
• Report Number: 3008114965-2018-00563
• Device Sequence Number: 10861589
• Product Code: KRD
• UDI-Device Identifier: 10886704080282
• UDI-Public: 10886704080282
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K171862
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 02/19/2018

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: 09/30/2020
• Device Catalogue Number: GLM925055
• Device Lot Number: S15116
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/19/2018
• Initial Report FDA Received Date: 03/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1