MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number GLX120306

Device Problems Difficult To Position (1467); Material Protrusion/Extrusion (2979)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/25/2017

Event Type  malfunction  

Manufacturer Narrative

Procode: krd/hcg.(b)(4).Information regarding patient age, gender, weight and medical history is not available.Additional information will be submitted within 30 days of receipt.

Event Description

As reported by a healthcare professional, two galaxy g3 coils (gly120308/s11506 and glx120306/s12256) and 1 mircus frames coil (mfr100305/lot unk) were not able to be advanced completely into the aneurysm before pushing the excelsior sl-10 45 microcatheter back into the parent vessel.Four non-codman coils were then advanced completely without any difficulty.There was no death or serious injury and no additional medical intervention was required.The patient condition was good.There was medium vessel tortuosity.

Manufacturer Narrative

Additional information received 10/20/2017: there was no resistance during advancement of the coils through the microcatheter and a continuous flush had been maintained through the microcatheter.There had been no difficulty in getting the coils to confirm to the walls of the small posterior communicating artery aneurysm and the events did not result in disruption/reduction in cerebral blood flow.There was no difficulty in removing the coils through the microcatheter.The events resulted in a 20 minute procedure delay, and there was no patient injury.Conclusion: as reported by a healthcare professional, two galaxy g3 coils (gly120308/s11506 and glx120306/s12256) and 1 mircusframe s coil (mfr100305/lot unk) were not able to be advanced completely into the aneurysm before pushing the excelsior sl-10 45 microcatheter back into the parent vessel.There was no resistance during advancement of the coils through the microcatheter and a continuous flush had been maintained through the microcatheter.There had been no difficulty in getting the coils to confirm to the walls of the small posterior communicating artery aneurysm and the events did not result in disruption/reduction in cerebral blood flow.There was no difficulty in removing the coils through the microcatheter.The events resulted in a 20-minute procedure delay, and there was no patient injury.Four non-codman coils were then advanced completely without any difficulty.The patient condition was good.There was medium vessel tortuosity.The devices were not available for analysis.The galaxy g3 product was not returned for investigation.A review of manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection processes related to the reported complaint.A nonconformance was generated to evaluate potential contamination in a bottle of neutralizer.Product was released as acceptable.All product rejected during manufacturing was identified as scrap and properly accounted for.The positioning difficulty with coil herniation into the parent vessel could not be confirmed without product return for analysis.The root cause of the event could not be determined; however, the excelsior microcatheter may have contributed to the event.There is no current safety signal identified related to the reported events based on review of complaint histories for the devices.Since there was no evidence to suggest the event was related to a manufacturing issue, no corrective actions will be taken at this time.

• Brand Name: GALAXY G3
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; rue girardet 29; le locle jura ; SZ
• Manufacturer Contact: joaquin kurz ; 47709 freemont blvd; freemont, CA 94538 ; 9497899383
• MDR Report Key: 6964124
• MDR Text Key: 90663160
• Report Number: 3013875781-2017-00009
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 10886704077695
• UDI-Public: (01)10886704077695(17)190930(10)S12256
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150319
• 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,Followup
• Report Date: 09/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: GLX120306
• Device Lot Number: S12256
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1