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

Catalog Number	641CX3575
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is initial mdr report being submitted for this complaint with associated mfr# 2954740-2017-00094.Additional procode: krd.(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.No conclusion is made at this time.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
As reported by a healthcare professional, during coiling of an aneurysm a resistance was experienced when using a galaxy g2 3.5x7.5 coil.The coil was introduced into an unknown coiling microcatheter; however, it became stuck and broke off in the catheter.There were no adverse events associated with this device failure.The procedure was delayed by 10 minutes.The broken device was easily removed without additional intervention.It is unknown if the complaint device is available for investigation.
Additional Manufacturer Narrative
This is final mdr report being submitted for this complaint with associated mfr# 2954740-2017-00094.The orbit galaxy g2 coil was not returned for investigation therefore the root cause of the coil¿s resistance and separation in the patient could not be determined.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.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: 6551717
• Report Number: 2954740-2017-00094
• Device Sequence Number: 16416410
• Product Code: HCG
• UDI-Device Identifier: 10878528008979
• UDI-Public: (01)10878528008979(17)200331(10)P10448
• Combination Product (Y/N): N
• 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): 04/17/2017

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: 03/31/2020
• Device Catalogue Number: 641CX3575
• Device Lot Number: P10448
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/17/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/08/2017
• Supplement Report FDA Received Date: 06/09/2017
• Patient Sequence Number: 1