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

Catalog Number 641CX0410

Device Problem Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/15/2017

Event Type  malfunction  

Manufacturer Narrative

Procode: krd/hcg.Concomitant medical products: enpower cables (ecb00018200/s13482 and ecb00018200/s13745).It was reported that the product would be returned for analysis; however, the product has not yet been returned.Additional information will be submitted within 30 days of receipt.

Event Description

As reported by a healthcare professional, during coil embolization of an anterior communicating artery aneurysm, a g2 tdl complex xtrasoft coil (641cx0410/ s12732) failed to detach using two detachment cables (ecb00018200/s13482 and ecb00018200/ s13745), and during withdrawal, the echelon 10 microcatheter target access was lost and it was decided to place no further coils.It was reported that after the coil failed to detach, the detachment control cable and detachment control box (dcb00000500/c20653) were replaced and detachment procedure was repeated, but without success.Finally, the coil was retracted, but target access was lost and it was decided to place no other coils.There had been no resistance between the g2 and the microcatheter during advancement or withdrawal.The entire coil was removed from the microcatheter and the microcatheter was still attached to the delivery system and was not stretched.Pre-deployment electrical check was performed.No low battery light was seen during the case and no fault light was seen.Upon pressing the power button, all lights illuminated.Only during the first attempt at detachment did the detachment light illuminate and the audible signal beep.All connections appeared to fit properly without application of excessive force.The same detachment control box was later used successfully during other procedures.The patient had no adverse events as a result of the event, but the procedure was delayed about 20 minutes.

Manufacturer Narrative

Additional information will be submitted within 30 days of receipt.

• 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: 6787788
• MDR Text Key: 82894564
• Report Number: 2954740-2017-00225
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 10878528009389
• UDI-Public: (01)10878528009389(17)211231(10)S12732
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 07/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 641CX0410
• Device Lot Number: S12732
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1