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

Catalog Number	641CX0202
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is initial mdr report being submitted for this complaint with associated mfr # 2954740-2017-00027.Additional pro code: krd.(b)(4).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 product is expected to be returned for analysis, however it has not been received.Additional information will be submitted within 30 days of receipt.No conclusions are made at this time.
Event or Problem Description
As reported by health care professional, a g2 complex xtrasoft coil got stuck in a micro catheter (competitor¿s device) and got stretched.The patient was diagnosed with subarachnoid hemorrhage and the procedure was for coiling of anterior communicating artery aneurysm.It was reported that prior to the complaint coil three coils were inserted through the same microcatheter without any resistance.The resistance with the complaint coil was felt before the coil exited the microcatheter; when the coil was being advanced through the mid shaft of the catheter.After stretching was noted the entire coil was successfully removed from the patient with the coil still attached to the delivery system.Only the complaint coil was removed, the reported event did not require the removal of the catheter.There were no adverse events or surgical delays due to the reported event.There were no kinks noted on the microcatheter and an adequate continuous flush was maintained through the catheter at all times.It was initially reported that the complaint product is available for return.
Additional Manufacturer Narrative
This is final mdr report being submitted for this complaint with associated mfr # 2954740-2017-00027.Product returned for evaluation: limited information was received.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 returned 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.All location and measurement callouts are approximate and for reference only.The coil was stretched and the stretch resistant suture was severed.No manufacturing defects were found.The complaint of the coil stretching is confirmed.Without the return of the echelon 10 microcatheter and due to the severe damage to the coil, the root cause of the coil stretching cannot be determined, however the evidence as received highly suggests that the coil was temporarily anchored and when the coil was retracted it stretched.The source and location of this interference and whether it was of a fixed or detached nature cannot be determined.In addition, without the return of 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 coils resistance inside the microcatheter cannot be confirmed.Without the return of the echelon 10 microcatheter and due to the post-procedural cleaning that left the returned microcoil system in pristine condition, the root cause of the coils resistance inside the microcatheter cannot be determined, however it is possible that distal interference of an unknown source and location may have caused interference to the coil thereby producing the resistance encountered by the end user.It also cannot be determined if the interference was of a fixed or detached nature.The fact that the coil was temporarily anchored in the microcatheter and was stretched during removal supports the distal interference as a contributing factor.In addition, without the return of the echelon 10 microcatheter and the rhv used in the procedure, it cannot be determined if these components contributed to the complaint event.A review of the manufacturing documentation associated with this lot (c267040) presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Based on the information and the analysis, the reported event of coil stretching was confirmed and the reported event of resistance inside the catheter cannot be determined.Without the return of the echelon 10 microcatheter and due to the severe damage to the coil, the root cause of the coil stretching and resistance inside the catheter cannot be determined.Although a definitive conclusion cannot be made, based on the analysis, it appears that distal interference in the microcatheter was the primary cause of the event.Other contributing factors appear to be procedural in nature.Additionally, review of 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: 6321645
• Report Number: 2954740-2017-00027
• Device Sequence Number: 16317082
• Product Code: HCG
• UDI-Device Identifier: 10878528008894
• UDI-Public: (01)10878528008894(17)190430(10)C26704
• 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): 01/19/2017

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: 04/30/2019
• Device Catalogue Number: 641CX0202
• Device Lot Number: C26704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/19/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/10/2017
• Supplement Report FDA Received Date: 02/28/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ECHELON 10 (MEDTRONIC) MICROCATHETER