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

Catalog Number	GLY123575
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Procode: krd/hcg.Concomitant product: duo eclilpse balloon, headway microcatheter.It was reported that the device would be returned for analysis; however, the device has not yet been returned.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
As reported by a healthcare professional, during treatment of a small, malformed aneurysm, a galaxy g3 (gly123575/s11528) stretched during repositioning of the coil in the aneurysm.The event occurred when the aneurysm was 29% filled.It was reported that the filling was successful because the aneurysm was small and malformed.The coil was removed still attached to the dpu.Neck remodeling had been performed with a duo eclipse balloon.A continuous flush had been maintained through the microcatheter.Another coil had passed through the same microcatheter prior to this event.There were no adverse patient consequences or procedure delay, and the procedure was completed with other spectra coils.It was reported that the device would be returned for analysis.
Additional Manufacturer Narrative
Dhr review was completed on 12/4/2017: the (b)(6) 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.The device has not yet been returned.
Additional Manufacturer Narrative
The device was returned for analysis on 1/16/2018.Complaint conclusion: as reported by a healthcare professional, during treatment of a small, malformed aneurysm, a galaxy g3 (gly123575/s11528) stretched during repositioning of the coil in the aneurysm.The event occurred when the aneurysm was 29% filled.It was reported that the filling was successful because the aneurysm was small and malformed.The coil was removed still attached to the dpu.Neck remodeling had been performed with a duo eclipse balloon.A continuous flush had been maintained through the microcatheter.Another coil had passed through the same microcatheter prior to this event.There were no adverse patient consequences or procedure delay, and the procedure was completed with other spectra coils.The device was returned for analysis.The device was returned with a piece of absorbent material and its outer package label.The outer package label matches the product documented in the complaint.The embolic coil was detached from the device positioning unit (dpu) and was stretched.The resheathing tool has been advanced all the way to the green introducer.The dpu was coiled and wound around itself, and the coil was bent in two locations.The ball tip was intact.The proximal solder ring was present.The non-stretched section of the embolic coil was not kinked.The resistance heating (rh) coil had not heated.The resheathing tool was undamaged.A review of manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection processes related to the reported complaint.The complaint that the embolic coil stretch was confirmed.The proximal end of the embolic coil was stretched.The coil had also mechanically detached from the dpu.According to the information provided, detachment must have occurred after the embolic coil was removed from the microcatheter as it was still attached to the dpu when it was removed.The entire coil was returned, as evidenced by the presence of both the ball tip and the proximal solder ring attached to the embolic coil.Also, according to the information provided, stretching occurred while the coil was being repositioned, and at least one additional embolic coil and a balloon were present at the treatment site.The evidence that a large segment of the embolic coil was neither stretched nor kinked suggests that the coil was partially restrained at the treatment site, possibly with one or more of the other devices present at the time.The stretched embolic coil indicated that excessive force was applied to the device, possibly in an attempt to release it from the restrained position.The damage to the dpu core wire appears to have occurred after the device was coiled for storage and/or shipping, and so occurred after the reported event.There is no current safety signal identified related to the reported event based on review of complaint history for the device.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.

• Brand Name: GALAXY G3
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; rue girardet 29; le locle jura ; SZ
• MDR Report Key: 6915827
• Report Number: 2954740-2017-00283
• Device Sequence Number: 1460968
• Product Code: HCG
• UDI-Device Identifier: 10886704077435
• UDI-Public: (01)10886704077435(17)190731(10)S11528
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/12/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: GLY123575
• Device Lot Number: S11528
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2018
• Initial Date Received by Manufacturer: 09/12/2017
• Supplement Date Received by Manufacturer: 12/04/2017; 01/16/2018
• Initial Report FDA Received Date: 10/05/2017
• Supplement Report FDA Received Date: 12/21/2017; 01/30/2018
• Patient Sequence Number: 1