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

Catalog Number	641CX0410
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Procode: krd/hcg.Concomitant medical products: enpower cables (ecb00018200/s13482 and ecb00018200/s13745).It was reported that the product would be returned for analysis; however, the product has not yet been returned.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
As reported by a healthcare professional, during coil embolization of an anterior communicating artery aneurysm, a g2 tdl complex xtrasoft coil (641cx0410/ s12732) failed to detach using two detachment cables (ecb00018200/s13482 and ecb00018200/ s13745), and during withdrawal, the echelon 10 microcatheter target access was lost and it was decided to place no further coils.It was reported that after the coil failed to detach, the detachment control cable and detachment control box (dcb00000500/c20653) were replaced and detachment procedure was repeated, but without success.Finally, the coil was retracted, but target access was lost and it was decided to place no other coils.There had been no resistance between the g2 and the microcatheter during advancement or withdrawal.The entire coil was removed from the microcatheter and the microcatheter was still attached to the delivery system and was not stretched.Pre-deployment electrical check was performed.No low battery light was seen during the case and no fault light was seen.Upon pressing the power button, all lights illuminated.Only during the first attempt at detachment did the detachment light illuminate and the audible signal beep.All connections appeared to fit properly without application of excessive force.The same detachment control box was later used successfully during other procedures.The patient had no adverse events as a result of the event, but the procedure was delayed about 20 minutes.
Additional Manufacturer Narrative
Additional information will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
The concomitant connecting cables were returned for analysis.Analysis found no issues that could be related to the detachment failure.
Additional Manufacturer Narrative
There is no new information to report at this time.The report is being submitted to correct the sequential numbering of the follow-up reports per fda's request.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.No: (b)(4).
Additional Manufacturer Narrative
The device was returned for analysis on 8/14/2017.The analysis has not yet been completed.Additional information will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
Conclusion: as reported by a healthcare professional, during coil embolization of an anterior communicating artery aneurysm, a g2 tdl complex xtrasoft coil (641cx0410/ s12732) failed to detach using two detachment cables (ecb00018200/s13482 and ecb00018200/ s13745), and during withdrawal, the echelon 10 microcatheter target access was lost and it was decided to place no further coils.It was reported that after the coil failed to detach, the detachment control cable and detachment control box (dcb00000500/c20653) were replaced and detachment procedure was repeated, but without success.Finally, the coil was retracted, but target access was lost and it was decided to place no other coils.There had been no resistance between the g2 and the microcatheter during advancement or withdrawal.The entire coil was removed from the microcatheter and the microcatheter was still attached to the delivery system and was not stretched.Pre-deployment electrical check was performed.No low battery light was seen during the case and no fault light was seen.Upon pressing the power button, all lights illuminated.Only during the first attempt at detachment did the detachment light illuminate and the audible signal beep.All connections appeared to fit properly without application of excessive force.The same detachment control box was later used successfully during other procedures.The patient had no adverse events as a result of the event, but the procedure was delayed about 20 minutes.The g2 tdl complex xtrasoft coil was returned with its inner pouch.The labeling on the inner pouch matched the device documented in the complaint.The embolic coil was located in the green introducer.The device was fully unsheathed and the resheathing tool was advanced all the way to the green introducer.The proximal end of the embolic coil with the articulating joint was exposed in the v-notch of the resheathing tool.The distal end of the dpu was wound around the translucent introducer sheath and kinked.There are no visible kinks or bends in the dpu core wire.The rh coil appears to have received heat and melted; there was also blood present on the articulating joint and rh coil.The fiber had not detached.There was also blood in the green introducer.The ball tip was intact.The resistance of the coil unit was tested.The result was 49.0, which is within the specification range of 48.5 ¿ 56.The dpu was connected to a lab sample dcb, which was turned on; the system ready light illuminated.Advancement of the embolic coil out of the green introducer was attempted in order to test detachment of the coil.The embolic coil could not advance and the dpu protruded from the translucent introducer sheath when the resheathing tool was moved away from the green introducer.Detachment functionality could not be tested because the embolic coil could not be advanced out of the green introducer.A review of manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection processes related to the reported complaint.The enpower control cables were not returned for investigation.A review of manufacturing documentation associated with these lots presented no issues during the manufacturing or inspection processes related to the reported complaint.The complaint of failure to detach was confirmed.The rh coil appeared to have received heat, yet the embolic coil is still attached.The electrical connection in the dpu was good, as evidenced by the resistance test and the system ready light illuminating when the dcb is connected.Detachment could not be tested directly since the blood in the green introducer and the exposure of the articulating joint through the resheathing tool prevented the embolic coil from being advanced outside of the green introducer.In addition, the state of the rh coil indicates that a detach cycle had been successfully initiated, but the embolic coil did not detach.Without the return of the enpower connecting cables and the detachment control box, it is not possible to determine if they may have contributed to the detachment failure.There is no current safety signal identified related to the reported events based on reviews of complaint histories for the devices.Since there was no evidence to suggest the event was related to 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
• Manufacturer Contact: karen anigbo ; 821 fox lane; san jose, CA 95131 ; 5088288374
• MDR Report Key: 6787788
• Report Number: 2954740-2017-00225
• Device Sequence Number: 114369
• Product Code: HCG
• UDI-Device Identifier: 10878528009389
• UDI-Public: (01)10878528009389(17)211231(10)S12732
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K120686
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/18/2017

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: 12/31/2021
• Device Catalogue Number: 641CX0410
• Device Lot Number: S12732
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/18/2017
• Supplement Date Received by Manufacturer: 07/18/2017; 03/24/2025
• Initial Report FDA Received Date: 08/11/2017
• Supplement Report FDA Received Date: 08/11/2017; 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/07/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CONTINUED IN SECTION H10.
• Patient Sex: Unknown