MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 XSFT 3MM X 6CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLX120306
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).The purpose of this mdr submission is to report the findings of the device investigation.The embolic coil was found kinked, meeting regulatory reporting criteria.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Procode: krd/hcg.Initial reporter phone: (b)(6).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.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: as reported by the field, the procedure was for a type 2 endoleak (el), 3mm x 6cm galaxy g3 coil (glx120306, 30727836) was inserted by the coaxial technique with using a catheter (leonis mova hf) and a concomitant microcatheter (1.9 fr, carnelian marvel, tokai medical products).The lesion was reached with the beforementioned system.Coil preparation was not a problem.As the physician did not hold the carnelian marvel during coil placement, only the catheter was pulled back largely.The physician attempted to move the carnelian marvel back in position by advancing the catheter along the coil wire.However, the catheter got stuck and was not able to advance forward.The coil was removed with the concomitant microcatheter from the patient¿s body.The coil and the microcatheter were replaced with each new product.The procedure was completed.There were no post-procedure changes in the patient.There was no particular problem detected with the patient.A continuous flush was done.The lesion was lumbar artery.Additional information received indicated that the coil did not appear damaged at any time.There was nothing noted obstructing the microcatheter.No excessive force was applied to the device.Pre-shipment pictures were attached to the complaint file and it was noted that the device is attached and partially inside of another company's mc.The coil can be seen in the distal portion of the non-j&j microcatheter, and it was noted to be kinked.It remains attached to the resistance heating.Also, the core wire can be seen with a kinked condition.Only one section of the device can be seen in the picture.No other damages were observed.A manufacturing record evaluation was performed, and no non-conformances related to the reported complaint condition were identified.A non-sterile galaxy g3 xsft 3mm x 6cm was received contained in the decontamination pouch.Upon receiving the device, a visual inspection was performed, and it was noted that the device was returned partially inside of a non-j&j microcatheter, as seen in the pre-shipment pictures.The section of the device that was outside was inspected, and it could be noted that the core wire has a kinked condition near the distal fluorosaver marker band.The coil component was inspected under microscopic magnification, and it was noted to have multiple kinks.The device was flushed with a lab sample syringe to try to remove the device from the non-j&j microcatheter; however, this was not possible.The device remains stuck in the mc.The conditions described above precluded proper testing.Even to this, the customer complaint was confirmed since the device could not move.There is no indication that the issue reported in the complaint results from a defect inherently related to the device.Even though a continuous flush was reported, is possible that an adequate flush had not been done; without an adequate flush, issues such as resistance between the detachable coil delivery system (dcs) and the microcatheter can arise.It is possible that force may have inadvertently been applied during the coil advancement in an attempt to overcome the resistance, which resulted in the coil kinking and the kinked condition found in the core wire.It should be noted that failure could be caused by multiple factors.The instructions for use (ifu) do contain the following recommendations: ¿ if unusual friction is still noticed during advancement or retraction of the microcoil system, verify flush lines are open and properly pressurized.Then slowly withdraw the entire microcoil system and examine for damage.Replace it with a new microcoil system.If friction still exists, withdraw and examine the delivery catheter system.¿if repositioning of the microcoil is necessary, carefully observe the motion of the microcoil in respect to the dpu wire while retracting the microcoil under fluoroscopy.If the microcoil movement is not one-to-one with the dpu wire, or if repositioning is difficult, the microcoil may have become stretched and could possibly break.Gently remove and discard the microcoil system.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.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.
Event or Problem Description
As reported by the field, the procedure was for a type 2 endoleak (el), 3mm x 6cm galaxy g3 coil (glx120306, 30727836) was inserted by the coaxial technique with using a catheter (leonis mova hf) and a concomitant microcatheter (1.9 fr, carnelian marvel, tokai medical products).The lesion was reached with the beforementioned system.Coil preparation was not a problem.As the physician did not hold the carnelian marvel during coil placement, only the catheter was pulled back largely.The physician attempted to move the carnelian marvel back in position by advancing the catheter along the coil wire.However, the catheter got stuck and was not able to advance forward.The coil was removed with the concomitant microcatheter from the patient¿s body.The coil and the microcatheter were replaced with each new product.The procedure was completed.There were no post-procedure changes in the patient.There was no particular problem detected with the patient.A continuous flush was done.The lesion was lumbar artery.Additional information received indicated that the coil did not appear damaged at any time.There was nothing noted obstructing the microcatheter.No excessive force was applied to the device.Based on the visual analysis of the picture received, the coil is kinked.

• Brand Name: GALAXY G3 XSFT 3MM X 6CM
• 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: 15294478
• Report Number: 3008114965-2022-00563
• Device Sequence Number: 2658252
• Product Code: KRD
• UDI-Device Identifier: 10886704077695
• UDI-Public: 10886704077695
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/25/2022

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: 12/31/2024
• Device Model Number: GLX120306
• Device Catalogue Number: GLX120306
• Device Lot Number: 30727836
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2022
• Initial Report FDA Received Date: 08/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2022
• 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, CARNELIAN MARVEL, TOKAI MEDICAL PRODUCTS; LEONIS MOVA HF CATHETER
• Patient Sex: Unknown