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

Model Number	GLM910040
Medical Device Problem Codes	Stretched (1601); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The healthcare professional reported that during the endovascular embolization procedure, the 1.00mm x 4.00cm galaxy g3 mini (glm910040 / l15855) was the third coil used; it could not be advanced nor retrieved by the physician.The physician removed the complaint coil and the concomitant microcatheter at the same time.After inspection, it was observed that the coil was stretched.The physician used another coil and the procedure was successfully completed.There was no report of any patient adverse event or complication.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Procode is krd/hcg.Device evaluated by mfr: the device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation.If the device returns, a device investigation will be performed.A review of manufacturing documentation associated with this lot (l15855) 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.This report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by cerenovus, or its employees that the report constitutes an admission that the product, cerenovus, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product was received the product analysis lab on 05-may-2022.The return product is pending evaluation.A supplemental 3500a report will be submitted once the product investigation has been completed.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.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigational finding of the returned device.[conclusion]: the healthcare professional reported that during the endovascular embolization procedure, the 1.00mm x 4.00cm galaxy g3 mini (glm910040 / l15855) was the third coil used; it could not be advanced nor retrieved by the physician.The physician removed the complaint coil and the concomitant microcatheter at the same time.After inspection, it was observed that the coil was stretched.The physician used another coil and the procedure was successfully completed.There was no report of any patient adverse event or 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 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 was received.The returned device was visually inspected.No observable damages were noted, all the components were returned in good normal conditions (i.E., no kinks on the introducer or the core wire, no protrusions).The embolic coil was advanced through the introducer until it reached the distal end of the introducer and came out, and no resistance was felt during the test.Under microscopic magnification, the embolic coil was found to be in good and normal conditions outside the introducer.The embolic coil was retracted to the introducer; then, it was advanced through a flushed lab sample microcatheter and no resistance was felt during the test.The embolic coil was inspected once again under microscopic magnification, and it was found to be in good and normal conditions (i.E.No kinks, elongations, or non-concentric loops).The reported issue documented in the complaint could not be confirmed since the galaxy g3 performed without any problem.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.The appearance of the returned device does not suggest that it was subjected to excessive force to overcome the friction with the microcatheter.A review of manufacturing documentation associated with this lot (l15855) 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.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) contain the following precautions: if unusual friction is noticed during advancement or retraction of the microcoil system through the introducer, open the rhv main valve, and partially withdraw the distal end of the introducer to expose its tip within the rhv.Tighten the rhv main valve and flush the y-connector of the rhv with sterile saline and verify that fluid exits the slit in the clear portion of the introducer.Do not fasten the rhv valve too tightly around the introducer sheath since excessive pressure may cause damage to the introducer sheath and/or the microcoil as it is advanced into the infusion microcatheter.Based on the manufacturing documentation 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.

• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-7981
• MDR Report Key: 14079309
• Report Number: 3008114965-2022-00232
• Device Sequence Number: 14771393
• 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,Followup,Followup
• Report Date (Section B): 05/19/2022

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: 04/30/2022
• Device Model Number: GLM910040
• Device Catalogue Number: GLM910040
• Device Lot Number: L15855
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2022
• Supplement Date Received by Manufacturer: 05/05/2022; 05/19/2022
• Initial Report FDA Received Date: 04/11/2022
• Supplement Report FDA Received Date: 05/06/2022; 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2019
• 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