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

Catalog Number	641CF0201
Medical Device Problem Codes	Stretched (1601); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/14/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Additional information will be submitted within 30 days of receipt.
Event or Problem Description
It was reported by a healthcare professional that during an elective coiling procedure to treat a secular moderately wide neck acom aneurysm a g2 complex fill coil 2x1.5 (b)(4) got stretched while repositioning.The coil was removed along with the echelon 10 microcatheter and slight resistance was felt.No resistance was encountered between the guidewire and the microcatheter when accessing the target site.Nor was there any resistance when advancing the coil through the microcatheter.Other coils had successfully been passed through the same microcatheter without issue.The g2 complex fill coil 2x1.5 (complaint product) was the last coil attempted to fill the neck.A one to one relationship between the coil and delivery tube was not verified with fluoro prior to repositioning.Additional intervention was not required as the case was abandoned.There were no patient complications or procedural delay as a result of this event.Reportedly, the aneurysm was 4mm in height, 3.5mm in width, and the neck was 2.5mm with normal vessel characteristics.Neck remodeling was not utilized during this procedure.An adequate continuous flush was maintained through the microcatheter at all times.There were no kinks noted in the microcatheter.
Additional Manufacturer Narrative
This is final mdr report being submitted for this complaint with associated mfr# 2954740-2017-00004.It was reported by a healthcare professional that during an elective coiling procedure to treat a secular moderately wide neck anterior communicating aneurysm a g2 complex fill coil 2x1.5 (641cf0201/c13335) got stretched while repositioning.The coil was removed along with the echelon 10 microcatheter and slight resistance was felt.No resistance was encountered between the guidewire and the microcatheter when accessing the target site.Nor was there any resistance when advancing the coil through the microcatheter.Other coils had successfully been passed through the same microcatheter without issue.The g2 complex fill coil 2x1.5 (complaint product) was the last coil attempted to fill the neck.A one to one relationship between the coil and delivery tube was not verified with fluoro prior to repositioning.Additional intervention was not required as the case was abandoned.There were no patient complications or procedural delay as a result of this event.Reportedly, the aneurysm was 4mm in height, 3.5mm in width, and the neck was 2.5mm with normal vessel characteristics.Neck remodeling was not utilized during this procedure.An adequate continuous flush was maintained through the microcatheter at all times.There were no kinks noted in the microcatheter.The g2 complex fil coil was returned for analysis.The echelon 10 microcatheter and the rotating hemostatic valve (rhv) were not returned.Concerning cleanliness only, the microcoil system was returned in almost pristine condition.The system was either not used or was cleaned before being returned which may have produced further damage.It is also unknown if the device was improperly handled for return packaging or was further manipulated and/or inspected post-procedurally.In addition, any trace or other evidence that may have been complaint related may have been altered or removed prior to being returned due to post-procedural handling, cleaning, and packaging.The complaint of resistance to the coil during removal cannot be confirmed.Due to severe coil stretching, where the resistance occurred inside the patient, and without the return of the microcatheter used in the procedure, the root cause of the coils resistance during removal cannot be determined; however, the evidence as received highly suggests that during repositioning the coil may have been temporarily anchored on the coils already dwelling inside the target site, on itself, or on the distal tip of the microcatheter if placed at an acute angle.In addition without the echelon 10 microcatheter and the rhv used in the procedure, it cannot be determined if these components contributed to the complaint event.The complaint of the coil stretching is confirmed, however it cannot be confirmed if it occurred during repositioning as stated in the complaint.While the root cause of the coil stretching cannot be determined, the evidence as received highly suggests that during repositioning, the coil may have been temporarily anchored on the coils already dwelling inside the target site, on itself, or on the distal tip of the microcatheter if place at an acute angle.When the anchored coil was retracted it may have stretched.In addition without the echelon 10 microcatheter and the rhv used in the procedure, it cannot be determined if these components contributed to the complaint event.There were no other damages found on the unit.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.Therefore, 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: 6230682
• Report Number: 2954740-2017-00004
• Device Sequence Number: 13642163
• Product Code: KRD
• UDI-Device Identifier: 10878528009426
• UDI-Public: (01)10878528009426(17)171019(10)C13335
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K120686
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2016

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: 10/19/2017
• Device Catalogue Number: 641CF0201
• Device Lot Number: C13335
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/15/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/06/2017
• Supplement Report FDA Received Date: 02/16/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ECHELON 10 MICROCATHETER