MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	641CF0620
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This initial mdr will be the only report submitted for mfr report #2954740-2017-00274.D2b: krd/hcg.(b)(4).The product will not be returned for analysis however a device history record review is currently being conducted and the results are not yet available.
Event or Problem Description
It was reported by a healthcare professional that a g2 cmplx fill coil (641cf0620/s10184) was used during a procedure where the coil could not be detached.The coil was delivered, but not deployed.The coil was then re-sheathed and re-deployed but the coil would not detach.The coil was removed and discarded.
Additional Manufacturer Narrative
This final mdr will be the only report submitted.Conclusion: based on the information, the event could not be confirmed.The product was not returned for analysis; however a review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Therefore, no corrective actions will be taken at this time.

• Brand Name: ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• MDR Report Key: 6886174
• Report Number: 2954740-2017-00274
• Device Sequence Number: 809287
• Product Code: KRD
• UDI-Device Identifier: 10878528009594
• UDI-Public: (01)10878528009594(17)210331(10)S10184
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K120686
• 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,Followup
• Report Date (Section B): 09/05/2017

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: 03/31/2021
• Device Catalogue Number: 641CF0620
• Device Lot Number: S10184
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/06/2017
• Supplement Date Received by Manufacturer: 10/19/2017
• Initial Report FDA Received Date: 09/22/2017
• Supplement Report FDA Received Date: 11/08/2017
• Patient Sequence Number: 1