MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 XSFT HEL 2MM X 4CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLX120204
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2022
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 stretched, meeting regulatory reporting criteria.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Procode: krd/hcg.A non-sterile galaxy g3 xsft hel 2mm x 4cm was received contained in the decontamination pouch.Upon receiving the device, a visual inspection was performed, and it could be noted that the coil protruded from the introducer.The device was inspected under microscopic magnification, and it was found that the embolic coil was protruding through a kink on the introducer.Also, the embolic coil was inspected, and it was found to be severely stretched; it remains attached to the resistance heating (rh) coil.No other damages were found in the device.Coil stretching is a known potential issue associated with the use of this device.The instructions for use (ifu) provides proper handling instructions for the device to prevent such issues from occurring.Stretching can occur during procedure handling where force may have been inadvertently applied.The stretched condition of the embolic coil was not originally reported in the complaint.According to the risk documentation, coil damage is a potential effect of the rotating hemostasis valve (rhv) fastened too tightly during microcoil placement; in this case, it was reported that there was resistance at the microcatheter hub during the initial advancement of the coil, which may have resulted in the coil stretching and introducer kinking.The complaint reported that no damage was noted on the sheath introducer, neither the delivery wire nor the coil was noted to be protruding from the introducer; but it is not clear whether such conditions were confirmed during the initial inspection of the device.The damages noted in the returned device suggest that it was subjected to excessive force in attempt to overcome the resistance, which ultimately led to the inability to resheath the coil.The customer complaint was able to be confirmed, however, here is no indication that the issue reported in the complaint is a result of a defect inherently related to the device.A manufacturing record evaluation was performed, and no non-conformances related to the reported complaint condition were identified.It should be noted that multiple factors could cause product failure.The instructions for use (ifu) does 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.Additionally, if the introducer tip and microcatheter hub are misaligned, damage may occur to the microcoil as it passes through this transition.During re-sheathing: pulling the exposed microcoil through the rhv grommet may damage the coil.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.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 803 (and/or part 4, as applicable).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.
Event or Problem Description
As reported by the field, during a coil embolization for a subarachnoid hemorrhage (sah), the re-sheathing tool for a galaxy g3 xsft hel 2mm x 4cm coil (glx120204, 30478873) failed to re-sheath.The same size and length of another coil was immediately opened for the physician to continue with the coiling procedure.Additional information was received indicating that resistance was encountered during the initial advancement of coil that required resheathing.An adequate continuous flush was maintained through the unspecified microcather (mc).There was no damage observed on the sheath introducer.It was not necessary to remove the microcatheter.The target site was the anterior communicating aneurysm accessed from the rica.Based on the product analysis of the device received, the embolic coil was found to be severely stretched.

• Brand Name: GALAXY G3 XSFT HEL 2MM 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16217965
• Report Number: 3008114965-2023-00059
• Device Sequence Number: 6033186
• Product Code: KRD
• UDI-Device Identifier: 10886704077749
• UDI-Public: 10886704077749
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/20/2023

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: 10/31/2023
• Device Model Number: GLX120204
• Device Catalogue Number: GLX120204
• Device Lot Number: 30478873
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2023
• Initial Report FDA Received Date: 01/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2020
• 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: UNSPECIFIED MICROCATHETER
• Patient Sex: Unknown