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

Catalog Number 641CF0615

Device Problem Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/22/2016

Event Type  malfunction  

Manufacturer Narrative

Common device name: krd/hcg.(b)(4).Conclusion: the device was not available for analysis.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 coil protruding into the parent vessel and resheathing difficulty could not be confirmed without product return for analysis or procedural films for review.The root cause of the events could not be determined; however, aneurysm characteristics (required stent to hold coils in place) may have contributed to the coil protrusion.Procedural/handling factors may have contributed to the resheathing issue.Since there was no evidence to suggest the events were related to a manufacturing issue, no corrective actions will be taken at this time.This is an initial/final mdr report.

Event Description

As reported by a healthcare professional, during coil of an unruptured, 6mm posterior communicating artery aneurysm, a g2 tdl complex fill coil (641cf0615/ p10015) protruded into the parent vessel during positioning, and could not be re-sheathed.Initially, after placing the sl10 microcatheter into the aneurysm, he decided to use the g2 fill coil to frame the aneurysm.After trying to deploy the coil, the physician decided that the aneurysm would need a stent since the stent could not be positioned and protruded into the parent vessel.At that time, he started to pull the coil back to be re-sheathed and used again after the stent was deployed.During re-sheathing, the zipper got stuck on the delivery sheath making it impossible to recapture the coil for reuse.The coil was set aside and accidentally discarded.The coil and delivery wire did not appear damaged after use.The patient suffered no harm by this issue, and the aneurysm was successfully treated.The event did not result in a clinically significant delay in the procedure.

• 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: 5885350
• MDR Text Key: 52394140
• Report Number: 2954740-2016-00183
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120686
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: 641CF0615
• Device Lot Number: P10015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SL-10 MICROCATHETER