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

Catalog Number 641CX2525

Device Problems Fracture (1260); Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/10/2017

Event Type  malfunction  

Manufacturer Narrative

This is initial mdr report for this complaint with associated mfr# 2954740-2017-00114.(b)(4).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 Description

It was reported by a healthcare professional that positioning difficulty was experienced with orbit galaxy g2 coil (b)(4) during the procedure which then got damaged.The coil was attempted to be placed twice however the attempts failed.The coil not conforming to the walls of the aneurysm when the physician was trying to position it.The coil was then taken out; when being removed the complaint coil cracked.The target vessel for the procedure was left internal carotid artery.The procedure was not delayed due to the reported event and the patient outcome was reported be good.The patient was a (b)(6) female with history of hypertension.The procedure was completed using a same like product.There were no damages noted on the complaint coil or the concomitant devices prior to use or upon removal.It was initially reported that the complaint product is available for return.

Manufacturer Narrative

This is final mdr report for this complaint with associated mfr# 2954740-2017-00114.The device was returned with the device positioning unit (dpu) advanced completely out of the translucent introducer body.Concerning cleanliness only, the microcoil system was returned in almost pristine condition.The system was either not used or was cleaned/rinsed before being returned which may have produced further damage.It is also unknown if the device was further manipulated and/or inspected post-procedurally.The embolic coil was still attached to the delivery system.The coil exhibits a stretch at the proximal end as exhibited by increased spacing between the first few concentric rings.The remainder of the coil exhibited no damage.There is no evidence of a detachment attempt as the resistive heating section is still intact with no melting.The entire length of the device positioning unit (dpu) core wire was inspected with the naked eye and under microscope and no damage was found.The complaint of the coil not conforming to the aneurysm walls could not be confirmed.Although there was a small stretched section at the proximal end of the embolic coil it is unknown whether this could have caused the coil conformity issue.There was no damage noted throughout the coil except for this small section.Therefore, it is unlikely that the coil was the sole cause of any potential issue conforming to the aneurysm.Although the root cause could not be determined multiple factors can contribute to the coil not conforming to the aneurysm wall.Factors can include decreased maneuverability due to the proximal stretch but also selection of the appropriate coil for the specific aneurysm and user technique.The complaint of the dpu being cracked is not confirmed.There was no damage found on any part of the dpu core wire.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.Based on the information and analysis, the reported event of the coil not conforming to the aneurysm walls could not be confirmed.The root cause of the reported failure could not be determined; however multiple factors could have caused the failure including procedural/handling factors and the stretched section on the proximal end of the coil.The complaint of the dpu being cracked is not confirmed.There was no damage found on any part of the dpu core wire.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
• Type of Device: 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: 6604229
• MDR Text Key: 76521610
• Report Number: 2954740-2017-00114
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 10878528008900
• UDI-Public: (01)10878528008900(17)210331(10)S10183
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K120686
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 641CX2525
• Device Lot Number: S10183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 51 YR