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

Catalog Number 641CF1030

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/25/2016

Event Type  malfunction  

Manufacturer Narrative

This is one of one initial mdr report being submitted for this complaint (b)(4), with associated manufacture report numbers of 2954740-2016-00056.(b)(4).Concomitant devices: prowler select lp-es, 45 degree tip (lot unknown); 6f envoy da xb mpc, 95cm (lot unknown); presidio coil (lot unknown) and g2 coils (lot unknown).The root cause of the reported product issue cannot be determined as the product was not returned 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.

Event Description

As reported by the healthcare professional, during an elective procedure the galaxy g2 complex fill coil (641cf1030/c32704) would not advance from the introducer into the microcatheter.The procedure was coil embolization of the dural arteriovenous fistula located at the right vertebral artery.The coil tested successfully outside the body per ifu instructions.The introducer was advanced into the hub of the microcatheter, the coil was then unlocked and advancement was attempted during which the introducer backed out of the rotating hemostatic valve (rhv).Coil was then withdrawn back into coil introducer and re-attempted at which time the coil would not advance from introducer into microcatheter.Upon removal of the coil from the rhv it was noted that the coil appeared to be bent or kinked, the coil was discarded.Other g2 coils and competitor's coils were used successfully prior to the complaint galaxy coil.There were no patient injuries or additional interventions due to the event.There was no surgical delay due to the reported event.The product is not available for analysis.

• Brand Name: ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM
• Type of Device: ARTIFICIAL 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: 5479708
• MDR Text Key: 39650760
• Report Number: 2954740-2016-00056
• 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: 02/25/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 641CF1030
• Device Lot Number: C32704
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/25/2016
• Initial Date FDA Received: 03/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1