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

Catalog Number	641CF1230
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Procode: krd/hcg.The device was returned for analysis; however, the analysis has not yet been completed.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
As reported by a healthcare professional, during coil embolization at an unknown location, an orbit galaxy g2 coil (641cf1230/ s10226) could not be detached.The same system was used successfully to detach a subsequent coil with no problem.There was no damage noted to any of the products used.No further information was given or could be provided.
Additional Manufacturer Narrative
Conclusion: as reported by a healthcare professional, during coil embolization at an unknown location, an orbit galaxy g2 coil (641cf1230/ s10226) could not be detached.The same system was used successfully to detach a subsequent coil with no problem.There was no damage noted to any of the products used.No further information was given or could be provided.The device was returned with its inner pouch.The labeling on the inner pouch matches the product documented in the complaint.The embolic coil is exposed, and part of the embolic coil was adhered to the adhesive from the inner pouch label.The embolic coil was carefully released from the adhesive.The device is fully unsheathed.The embolic coil is tangled around the coiled dpu.The resheathing tool is advanced all the way to the green introducer.The embolic coil was gently untangled from the dpu.There is a very slight bend in the dpu core wire at approximately 69 cm from the proximal end.The ball tip is intact and has some adhesive adhered to its surface.There are no kinks or stretched sections of the embolic coil.The articulating joint is intact.The rh coil has not received heat and melted.The v-notch is undamaged.Resistance of the embolic coil system was tested using multimeter 70042-04d.The resistance was 49.4 ¿, which is within the specification range of 48.5 ¿ 56 ¿.The device was attached to a detachment control box (dcb) and the power was turned on.The system ready light illuminated.The embolic coil system, connected to the dcb, was immersed in warmed enzyme solution and a detach cycle was initiated.The embolic coil did not detach.After the attempted detachment, the rh coil does not appear to have received heat.A review of manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection processes related to the reported complaint.The complaint that the embolic coil did not detach was confirmed.The coil did not detach under lab conditions, and the rh coil remained un-melted after the detach cycle was attempted.The device passed all release criteria, and continued to pass the resistance test after being returned.Since the issue is not detectable with current release testing, the cause of the complaint cannot be determined.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 of a manufacturing issue, 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: 6794614
• Report Number: 2954740-2017-00230
• Device Sequence Number: 129822
• Product Code: HCG
• UDI-Device Identifier: 10878528009662
• UDI-Public: (01)10878528009662(17)210331(10)S10226
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K120686
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2017

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: 641CF1230
• Device Lot Number: S10226
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2017
• Initial Date Received by Manufacturer: 07/24/2017
• Supplement Date Received by Manufacturer: 10/12/2017
• Initial Report FDA Received Date: 08/15/2017
• Supplement Report FDA Received Date: 10/13/2017
• Patient Sequence Number: 1