MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 MINI 3MM X 4CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLM930040
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, ethnicity, and medical history were not provided.Procode is krd/hcg.[conclusion]: the healthcare professional reported that during the endovascular embolization procedure with the target lesion on the m1 segment, there were several attempts to detach the 3.00mm x 4.00cm galaxy g3 mini coil (glm930040 / l14417) using the enpower detachment control box (dcb) and the enpower control cable, but the coil was not detaching.Additional information provided confirmed that a pre-deployment electrical check was not performed, the low battery light was not seen, all the lights illuminated when the power button was pressed, the system ready light illuminated and the audible signal beep was heard during the attempts to detach the coil.The coil was then withdrawn into the concomitant microcatheter and removed.It was reported that the coil was still attached to the delivery system when it was removed; it was not stretched when it was removed.Another 3.00mm x 4.00cm galaxy g3 mini coil was used to replace the complaint coil and was successfully used with the same enpower dcb and enpower control cable.The reported coil detachment issue did not result in any delay in the procedure; it was successfully completed.There was no report of any patient adverse event or complication.The complaint device was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: the non-sterile 3.00mm x 4.00cm galaxy g3 mini coil was returned contained in a pouch.Visual inspection was performed.The marker band was found at 39cm from the hub; this is within specification.The device was observed in normal, good condition.The embolic coil was not returned with the rest of the complaint device.No other damage or anomaly was observed during the visual inspection.Microscopic inspection was performed.The resistance heating (rh) coil showed evidence that it had been heated; an indication that the detachment cycle was initiated.The embolic coil was not returned.Functional evaluation could not be conducted without the embolic coil.The rh coil was heated.An indication that the coil was detached.A review of manufacturing documentation associated with this lot (l14417) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.The complaint reported that during the procedure, several attempts were made to detach the 3.00mm x 4.00cm galaxy g3 mini coil using the enpower detachment control box and the enpower control cable, but the coil failed to detach.The coil was still attached to the delivery system when it was removed.The reported issue could not be confirmed in the product analysis lab.The complaint device was returned without the embolic coil component.During microscopic inspection, the rh coil showed evidence that it had been heated, this is consistent with the reported several attempts to detach the coil.However, the embolic coil was not attached and was not returned with the rest of the complaint device.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.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.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
The healthcare professional reported that during the endovascular embolization procedure with the target lesion on the m1 segment, there were several attempts to detach the 3.00mm x 4.00cm galaxy g3 mini coil (glm930040 / l14417) using the enpower detachment control box (dcb) and the enpower control cable, but the coil was not detaching.Additional information provided confirmed that a pre-deployment electrical check was not performed, the low battery light was not seen, all the lights illuminated when the power button was pressed, the system ready light illuminated and the audible signal beep was heard during the attempts to detach the coil.The coil was then withdrawn into the concomitant microcatheter and removed.It was reported that the coil was still attached to the delivery system when it was removed; it was not stretched when it was removed.Another 3.00mm x 4.00cm galaxy g3 mini coil was used to replace the complaint coil and was successfully used with the same enpower dcb and enpower control cable.The reported coil detachment issue did not result in any delay in the procedure; it was successfully completed.There was no report of any patient adverse event or complication.

• Brand Name: GALAXY G3 MINI 3MM X 4CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• MDR Report Key: 11240871
• Report Number: 3008114965-2021-00013
• Device Sequence Number: 3559217
• Product Code: KRD
• UDI-Device Identifier: 10886704080329
• UDI-Public: 10886704080329
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K171862
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/11/2021

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: 11/30/2021
• Device Model Number: GLM930040
• Device Catalogue Number: GLM930040
• Device Lot Number: L14417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2021
• Initial Report FDA Received Date: 01/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1