MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 XSFT 4MM X 8CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLX120408
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the field during a implantation of a 4mm x 8cm galaxy g3 xsft coil (glx120408, l16656) was attempted to be used, but its size did not fit to the target lesion and the complaint product was removed from the target lesion.The sheath introducer got damaged during the re-sheath and the coil was not able to be re-sheathed.The complaint product was able to be removed from the patient¿s body.After that, a replacement coil was used, and the procedure was completed without any consequence.There were no adverse health effects, etc.To the patient.A continuous flush was done.The lesion was a-com.Concomitant device was a microcatheter (exselsior sl10).Additional information indicated that there was no report of the procedure being delayed due to the event.There was no resistance encountered during the procedure.It was not necessary to remove the microcatheter.Based on the product analysis of the device received, the embolic coil was found to be severely kinked and stretched.
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 and stretched, meeting regulatory reporting criteria.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Procode: krd/hcg.(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 during a implantation of a 4mm x 8cm galaxy g3 xsft coil (glx120408, l16656) was attempted to be used, but its size did not fit to the target lesion and the complaint product was removed from the target lesion.The sheath introducer got damaged during the re-sheath and the coil was not able to be re-sheathed.The complaint product was able to be removed from the patient¿s body.After that, a replacement coil was used, and the procedure was completed without any consequence.There were no adverse health effects, etc.To the patient.A continuous flush was done.The lesion was a-com.Concomitant device was a microcatheter (exselsior sl10).Additional information indicated that there was no report of the procedure being delayed due to the event.There was no resistance encountered during the procedure.It was not necessary to remove the microcatheter.The device was returned to cerenovus for further evaluation.A non-sterile galaxy g3 was received contained in the decontamination pouch.Upon receiving the device, visual inspection was performed, and the introducer of the galaxy g3 mini 2.5mm x 5.5cm (glm925055/ 30383055) was noted with an opened condition, causing the corewire to protrude.The core wire was found protruding from the introducer and it was found to be kinked.The introducer was inspected along its entire length and multiple damages were found on it.Some residues of dry blood were found inside the introducer.No other damages or anomalies were observed on the device during the visual inspection.Under microscopic magnification, the embolic coil was found to be severely kinked and stretched, it remains inside the introducer.No other damages were found.The customer complaint was confirmed based on the findings observed, the introducer was found with multiple damages, and these seem to be secondary to the re-sheathing difficulty condition reported and may relate to factors not described in this complaint (e.G., excessive force applied to the device).Coil kinking and coil stretching are known potential issues associated with the use of this device.The instructions for use (ifu) provides proper handling instructions for the device to prevent such issue from occurring.Such damages can occur during procedure handling where force may have been inadvertently applied.It is possible that force may have inadvertently been applied during the coil removal from the patient¿s body which resulted in the coil stretching.Similarly, coil kinking might have occurred during the coil advancement due to the manipulation required in an attempt to re-sheath the coil.A manufacturing record evaluation was performed, and no non-conformances related to the reported complaint condition were identified.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) do contain the following recommendations: ¿ 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.Assignment of root cause for the events remains speculative and inconclusive, based on the limited information provided and the evidence presented by the returned device; however, it is possible that clinical and procedural factors, including device manipulation and device interaction, may have contributed to the reported failures and damages on the returned 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.

• Brand Name: GALAXY G3 XSFT 4MM 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-7981
• MDR Report Key: 15103358
• Report Number: 3008114965-2022-00508
• Device Sequence Number: 17440143
• Product Code: KRD
• UDI-Device Identifier: 10886704077732
• UDI-Public: 10886704077732
• 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): 07/26/2022

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: 07/31/2022
• Device Model Number: GLX120408
• Device Catalogue Number: GLX120408
• Device Lot Number: L16656
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2022
• Initial Report FDA Received Date: 07/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: EXSELSIOR SL10 MICROCATHETER
• Patient Sex: Unknown