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

Catalog Number	641CX2505
Medical Device Problem Codes	Stretched (1601); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/29/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b: krd/hcg.Patient information (i.E.Weight, age, gender, medical history) was not provided.Conclusion: the coil was not available for analysis.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.The resistance between the g2 complex extrasoft coil and the non-codman microcatheter could not be confirmed without product return for analysis.It is not possible to determine the root cause of the event; however, the microcatheter or procedural/handling factors may have contributed to the event.Since there was 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.
Event or Problem Description
As reported by a healthcare professional, there was resistance while advancing a g2 complex xtrasoft coil (641cx2505/ s10323) through the sl10 microcatheter, and the g2 coil appeared stretched.The coil had been tested outside of the body per ifu instructions and the introducer was advanced into the hub of the microcatheter.The coil was unlocked and advancement was initially smooth and successful.The coil then offered resistance to advancement.The coil was retracted completely into the introducer and removed from the rhv.The same coil was then re-inserted into the rhv and advanced, initially with success and no resistance, but then the coil again offered resistance.The coil was removed again from the microcatheter, retracted completely into the introducer and was discarded; however, it was noted that the coil was stretched.The microcatheter did not appear damaged.A continuous flush had been maintained through the microcatheter.

• 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: 5969667
• Report Number: 2954740-2016-00211
• Device Sequence Number: 430629
• Product Code: HCG
• UDI-Device Identifier: 10878528008931
• UDI-Public: (01)10878528008931(17)210331(10)S10323
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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
• Report Date (Section B): 08/29/2016

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: 641CX2505
• Device Lot Number: S10323
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2016
• Initial Report FDA Received Date: 09/22/2016
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SL-10 STRAIGHT, 6F NEURON 070