MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 3MM X 8CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLY120308
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The healthcare professional reported that during a coil embolization for a gastrointestinal bleed, the 3mm x 8cm galaxy g3 coil (gly120308 / 30624687) was used, but it was unable to be detached.The complaint coil was replaced with another coil and the procedure was completed.It was reported that a concomitant 1.9 fr carry león microcatheter (utm) was used; it was reported that five (5) cerenovus coils were used in addition to the complaint coil and they were detached without any issue.The complaint indicated that it was not clear if continuous flush was maintained.Information related to the target lesion is unknown.There was no report of any patient adverse event or complication.The complaint coil is not available to be returned.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.Procode is krd/hcg.The name, phone and email address of the initial reporter are not available / reported.Conclusion: the healthcare professional reported that during a coil embolization for a gastrointestinal bleed, the 3mm x 8cm galaxy g3 coil (gly120308 / 30624687) was used, but it was unable to be detached.The complaint coil was replaced with another coil and the procedure was completed.It was reported that a concomitant 1.9 fr carry león microcatheter (utm) was used; it was reported that five (5) cerenovus coils were used in addition to the complaint coil and they were detached without any issue.The complaint indicated that it was not clear if continuous flush was maintained.Information related to the target lesion is unknown.There was no report of any patient adverse event or complication.The complaint coil is not available to be returned.Based on complaint information, the device is not available to be returned for analysis.A review of manufacturing documentation associated with this lot (30624687) 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.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.Failure to detach is a known potential issue associated with the use of this device.The instructions for use (ifu) contains several precautions related to this issue and includes instructions for troubleshooting the situation should it be encountered during use.With the information provided in the complaint and without the product available for analysis, the reported issue by the customer cannot be confirmed.Based on the review of the manufacturing documentation, there is no indication that the event is related to the device manufacturing process.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint sample; however, it is possible that clinical and procedural factors, including device manipulation / interaction, aneurysm size / vessel characteristics, device selection, and the concomitant microcatheter, may have contributed to the reported issue.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.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 17-feb-2022.[additional information]: on 17-feb-2022, additional information was received.The information indicated that the 3mm x 8cm galaxy g3 coil was successfully removed from the patient.It was not stretched when it was removed; it was still attached to the delivery system when it was removed from the patient.The information indicated that a pre-deployment electrical check was performed.The fault light was not seen during the case.Upon pressing the power button, all lights illuminated including the green system ready light.The audible signal beep was heard when during the detachment cycle and the detachment light illuminated.All connections fit without application of force.The reported issue that the coil failed to detach did not result in any clinically significant procedure delay.E.1: initial reporter phone: (b)(6).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 3MM X 8CM
• 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: 13518574
• Report Number: 3008114965-2022-00051
• Device Sequence Number: 4384746
• Product Code: KRD
• UDI-Device Identifier: 10886704077466
• UDI-Public: 10886704077466
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K150319
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2022

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: 07/31/2024
• Device Model Number: GLY120308
• Device Catalogue Number: GLY120308
• Device Lot Number: 30624687
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2022
• Supplement Date Received by Manufacturer: 02/17/2022
• Initial Report FDA Received Date: 02/11/2022
• Supplement Report FDA Received Date: 02/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 1.9 FR CARRY LEÓN MICROCATHETER (UTM)
• Patient Sex: Unknown