MAUDE Adverse Event Report: REFER TO SECTION H10 GALAXY G3 6MM X 15CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	GLY120615
Medical Device Problem Codes	Stretched (1601); Separation Failure (2547); Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Information regarding patient age/date of birth, gender, weight, height, medical history, race, and ethnicity was not reported.Procode: krd/hcg.Physical manufacturer name: codman and shurtleff inc., dba depuy synthes products, inc.(b)(4).Initial reporter occupation: supervisor.Physical manufacturer name: physical manufacturer name: codman and shurtleff inc., dba depuy synthes products, inc.(b)(4).The product is available for evaluation and testing; however, it has not been received to date.Additional information will be submitted within 30 days of receipt.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.
Event or Problem Description
As reported by a healthcare professional, during a coil embolization procedure, the user connected the 6mm x 15cm galaxy g3 (gly120615/l12856) coil delivery system to the control cable (unk catalog & lot), the green ¿system ready¿ light illuminated, the coil was then advanced to the aneurysm, and the ¿detach¿ button was pressed, but the embolic coil remained attached.The user repeated this fives times, but the coil failed to detach.The control cable was replaced, but there was still no detachment of the coil.The coil was replaced, and the procedure was completed successfully.The coil was successfully removed from the patient without need for additional intervention.The control cable was not used to detach subsequent coils.There was no report of consequence or impact to the patient.The length of time that the surgery was delayed to the event was not reported.It is not known if the user changed the detachment control box (dcb) at any point during the reported event, but the same dcb was used to detach subsequent coils.All connections appeared to fit properly without application of excessive force.It was not reported if the coil or control cable appeared damaged at any time.It is not known if the devices were handled and prepped according to the instructions for use (ifu).The coil will be returned for analysis.The control cable was discarded by the user and is thus not available for evaluation.No further information could be obtained.
Additional Manufacturer Narrative
Product complaint # (b)(4).[complaint conclusion] as reported by a healthcare professional, during a coil embolization of an aneurysm, the user connected the 6mm x 15cm galaxy g3 (gly120615/l12856) coil to the control cable (unk catalog & lot), the ¿system ready¿ light illuminated, the coil was then advanced to the aneurysm, and the ¿detach¿ button was pressed, but the coil failed to detach.The user repeated these steps fives times, but the coil remained attached.The control cable was replaced, but there was still no detachment of the coil.The coil was replaced, and the procedure was completed successfully.The coil was successfully removed from the patient without need for additional intervention.The control cable was not used to detach subsequent coils.No patient complications occurred as a result of the event.The length of time that the surgery was delayed due to the event was not reported.It is not known if the user changed the detachment control box (dcb) at any point during the reported event, but the same dcb was used to detach subsequent coils.All connections appeared to fit properly without application of excessive force.It is unknown if the coil or control cable appeared damaged at any time, or if the devices were handled and prepped according to the instructions for use (ifu).No further information could be obtained.A non-sterile 6mm x 15cm galaxy g3 was received inside of a pouch.Upon receipt of the complaint device, visual inspection was conducted.The hub connector of the device positioning unit (dpu) was undamaged, but the dpu core wire was found kinked at approximately 44cm and 91 cm from the proximal end.The distal marker band was seen at approximately 50 cm from hub connector, which is within specification.The device was returned with the embolic coil detached from the device.A portion of the embolic coil was seen tangled around the resheathing tool.The embolic coil was seen kinked and stretched.The resheathing tool was seen broken, but the v-notch of the resheathing tool was found undamaged.The introducer was seen unzipped and undamaged.The device was then examined under a microscope.The distal outer sheath was not softened, indicating that the resistance heating (rh) coil had not been heated and the embolic coil was likely mechanically detached at the detachment zone.The stretched, kinked, and tangled condition of the embolic coil observed during visual inspection was confirmed via microscopic inspection.Detachment could not be tested since the embolic coil was received detached from the device; however, the device was connected to multimeter and the resistance was measured within specification.The device was then connected to a lab enpower detachment control box (dcb2000500) and an enpower connecting cable.The dcb2 power was turned on and the system ready light illuminated.The ¿detach¿ button was pressed on the detachment control box.The distal outer sheath was seen softened, indicating that the resistance heating coil had successfully heated.A review of manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformances related to device manufacture or inspection.The customer report that the coil failed to detach could not be confirmed.The device could not be fully tested for detachment due to the condition in which it was returned.The distal outer sheath was returned not softened, so it is likely that embolic coil was detached mechanically by force.The detachment would have been readily evident to the user; therefore, the mechanical detachment likely occurred during post-procedure handling.The detachment control box and connecting cable were not returned and could not be evaluated for functionality; however, the device resistance measured within specification and it was successfully connected to a lab-supplied dcb and connecting cable with the ¿system ready¿ light illuminated.After the ¿detach¿ button was pressed, the distal outer sheath was examined and was noted to have been softened, indicating that the rh coil had heated successfully.The mechanical detachment, stetching, and kinking of the embolic coil, the damage to the resheathing tool, and the kinks in the dpu core wire are indicators of excessive force applied to the device.100% of devices are inspected for damage at quality control (qc) final inspection.Thus, it is very unlikely that the device left the manufacturing facility with the observed damage or with the embolic coil not properly attached.Failure to detach is a known potential product failure associated with the use of the device.The ifu contains several cautions relating to this situation, including instructions for troubleshooting the situation should it be encountered during use.The ifu states the following: ¿verify that the microcoil delivery system is fully connected, and no faults are indicated on the dcb.If a fault exists, reseat all connections between the dpu, the dcb, and the connecting cable.If a fault still persists, replace the connecting cable.If this does not correct the error, replace the dcb.If the microcoil delivery system still continues to have a fault, retrieve the microcoil and replace with a new microcoil system.If the system is free of faults, depress the detach button on the enpower dcb or the enpower control cable.The detach cycle light next to the button will illuminate and an intermittent tone will sound for the duration of the detachment cycle.If the light and audible tone do not activate, replace the dcb.After the light goes out and the tone stops, detachment of the microcoil from the dpu wire must be fluoroscopically verified by gently withdrawing the dpu wire back approximately one (1) mm.Observe if the microcoil has detached.If the microcoil did not detach and no fault light is illuminated or flashing, repeat the steps above.If a fault light is detected, the system ready light is not illuminated (blue dcb only), or there is no detachment after two detachment attempts, replace the dcb unit.If detachment still does not occur, carefully withdraw the entire microcoil system and redeploy a new microcoil system.¿ neither the product analysis nor the device history record review suggests that the failure could be related to the manufacturing process.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and the evidence presented by the returned device; however, it is possible that procedural and handling factors may have contributed to the reported failure and damages noted on the returned system.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective/preventive action may be triggered at a later time.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
Additional Manufacturer Narrative
Product complaint # = > (b)(4).The purpose of this mdr submission is to report that the product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.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.No non-conformances related to the reported complaint condition were identified.Additional information will be submitted within 30 days of receipt.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: GALAXY G3 6MM X 15CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): REFER TO SECTION H10; 47709 fremont blvd; fremont CA 94538
• MDR Report Key: 8341716
• Report Number: 3008114965-2019-00911
• Device Sequence Number: 16715516
• Product Code: KRD
• UDI-Device Identifier: 10886704077534
• UDI-Public: 10886704077534
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/04/2019

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: 05/31/2021
• Device Catalogue Number: GLY120615
• Device Lot Number: L12856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2019
• Initial Date Received by Manufacturer: 02/04/2019
• Supplement Date Received by Manufacturer: 02/23/2019; 04/03/2019
• Initial Report FDA Received Date: 02/14/2019
• Supplement Report FDA Received Date: 03/06/2019; 04/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1