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

Catalog Number	641HX0204
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Only the g2 coil (lot c25452) met mdr reporting criteria.Product code: krd/hcg.Concomitant medical products: envoy da guide catheter (67125695db/lot unk) and prowler lpes microcatheter (606s155fx/lot unk).Conclusion: the g2 coil (lot c25452) was returned for analysis.The coil was returned completely stretched and entangled.No manufacturing defects were found.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 complaint of the coil stretching was confirmed.While the exact root cause cannot be determined, the evidence as returned and reported highly suggests that the most likely contributing factor may have been due to the coil being temporarily anchored during retraction.While the exact source and location cannot be determined, the evidence from the complaint report suggests that when the prowler lpes was reported to have been pinched by the envoy da guiding catheter, the coil may have been temporarily anchored in this configuration and then stretched during removal.In addition, without the return of the envoy da guiding catheter used in the procedure, it cannot be determined if this component contributed to the complaint event.Since there was no 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 report.
Event or Problem Description
As reported by a healthcare professional, during embolization of a middle cerebral artery aneurysm, there were issues with three different coils, and a prowler lpes.Deltaxsft (dlx100206/c41704) would not take the proper shape proper shape in the aneurysm (did not take the path to the open area of the aneurysm).The position of the microcatheter was believed to have contributed to the coil performance.The coil was removed, resheathed and put on back table.We then attempted to use the coil at a later time, it was hydrated per ifu, and the coil would not advance out of the sheath.The coil did not appear damaged.A deltaxsft (dlx100256/c41706), like the previous coil, did not conform the way the physician wanted, and the position of the microcatheter was felt to have contributed to the positioning issue.The coil was removed for resheathing, but the sheath split open.The coil did not appear damaged during the procedure.Next, a g2 orbit galaxy (641hx0204/c25452) was introduced into the microcatheter and advanced, but it appeared that the envoy da guide catheter (67125695db/lot unk) seemed to pinch the end of the prowler lpes microcatheter (606s155fx/lot unk), and the g2 orbit galaxy would not advance.The coil was removed, so doctor could add a distal access catheter to the setup.The exchange was made via a guidewire, therefore, there was not loss of target position and the same microcatheter and envoy da were used to continue the procedure.Once the coil was removed, it was noted to be stretched.A continuous flush had been maintained through the catheters.There was no patient injury, but the events resulted in a 15 minute procedure delay.The procedure was completed successfully.

• 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: 6453287
• Report Number: 2954740-2017-00067
• Device Sequence Number: 658173
• Product Code: HCG
• UDI-Device Identifier: 10878528009396
• UDI-Public: (01)10878528009396(17)190209(10)C25452
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 03/13/2017

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: 02/09/2019
• Device Catalogue Number: 641HX0204
• Device Lot Number: C25452
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2017
• Initial Report FDA Received Date: 04/03/2017
• Patient Sequence Number: 1