MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 MINI 1MM X 4CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLM910040
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Procode is krd/hcg.Conclusion: the healthcare professional reported that during an endovascular embolization procedure, the coil component of the 1.00mm x 4.00cm galaxy g3 mini coil (glm910040 / k10217) was impeded and could not be advanced during the procedure.There was no report of any patient adverse event, no patient complication.The complaint device was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: a non-sterile 1.00mm x 4.00cm galaxy g3 mini coil was received.Visual inspection was performed.The coir wire and introducer were observed in good condition.There was no evidence of damage noted.Microscopic inspection was performed.Under magnification, the embolic coil component is observed in kinked condition inside the introducer.The introducer was flushed and it was concluded that nothing was obstructing the introducer.However, due to the kinked condition of the embolic coil, it could not be advanced out.This observation is possibly secondary to the reported issue that the coil was impeded and could not be advanced during the procedure.A review of manufacturing documentation associated with this lot (k10217) 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.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.The customer complaint was confirmed based on the findings noted on the embolic coil.However, no contributing factors could be identified from the device.The exact timing when this condition occurred could not be determined with the information available.It should be noted that product failure could be caused by multiple factors.The instructions for use do contain the following precaution: never advance, withdraw, or torque the delivery tube against resistance without first determining the cause of resistance under fluoroscopy.Manipulation of the delivery tube against resistance can cause damage and/or premature detachment of the coil.Coil kinking is a known potential issue associated with the use of the device.The instruction for use provides proper handling instructions for the device to prevent issues such as kink from occurring.The coil kinked condition was not originally reported with the complaint.The exact cause of the observed kinked condition could not be conclusively determined.It is possible that when the coil could not be advanced during the procedure, some force may have inadvertently been applied during the attempt to advance the coil.Multiple attempts were made to obtain information related to the procedure, to the reported device issue did not yield any response.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.Devices undergo 100% inspection at final assembly for the condition of the embolic coil.Thus, it is not likely that the 1.00mm x 4.00cm galaxy g3 mini coil left the manufacturing facility with the embolic coil in a kinked condition as observed on the returned device.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.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.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 an endovascular embolization procedure, the coil component of the 1.00mm x 4.00cm galaxy g3 mini coil (glm910040 / k10217) was impeded and could not be advanced during the procedure.There was no report of any patient adverse event, no patient complication.Multiple attempts to obtain additional information related to the procedure and the reported device issue were unsuccessful.If additional information is received at a later date, this file will be updated accordingly.The complaint devices were returned for evaluation and analysis.During the microscopic inspection of the 1.00mm x 4.00cm galaxy g3 mini coil (glm910040 / k10217), the embolic coil component was observed in a kinked condition inside the introducer.Based on the product analysis on 10-mar-2022, this event has been deemed mdr reportable as a ¿malfunction.¿.

• Brand Name: GALAXY G3 MINI 1MM 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
• Manufacturer (Section G): CODMAN & SHURTLEFF, INC. (FREMONT); 47709 fremont blvd; fremont CA 94538
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 949789-8687
• MDR Report Key: 13726976
• Report Number: 3008114965-2022-00187
• Device Sequence Number: 17665008
• Product Code: KRD
• UDI-Device Identifier: 10886704080251
• UDI-Public: 10886704080251
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/10/2022

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: 11/30/2022
• Device Model Number: GLM910040
• Device Catalogue Number: GLM910040
• Device Lot Number: K10217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2022
• Initial Report FDA Received Date: 03/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown