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

Model Number	GLM910010
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the field, prior to use, a 1mm x 1cm galaxy g3 mini coil (glm910010, 30392236) detached before the procedure.There was no patient injury as the device was not clinically used.
Additional Manufacturer Narrative
Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Procode:krd/hcg.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.Based on the visual analysis of the one photo accompanied with the compliant file.The device can be observed coiled inside of a pouch, a kink can be observed in the dpu at the marker bands section, and another kink was observed on the green section of the introducer near the tip introducer.Also, it can be observed that the embolic coil is no longer attached to the rest of the device, although the embolic coil could not be observed in the picture, and it is not possible to determine if the rh is heated, the detached condition noted on the embolic coil is related to the customer complaint.A manufacturing record evaluation was performed, and no non-conformances related to the reported complaint condition were identified.The customer complaint was confirmed.This investigation was performed based only on the photo provided.If the product is received after this investigation, an assessment will be performed as per the conditions of the device returned.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 company is seeking this information through the event investigation.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Updated sections on this medwatch: b4, , g3, g6, h2, h6, h6 and h10.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, prior to use, a 1mm x 1cm galaxy g3 mini coil (glm910010, 30392236) detached before the procedure.There was no patient injury as the device was not clinically used.No additional information is available.One photo accompanied the compliant file.In it, the device can be observed coiled inside of a pouch, a kink can be observed in the dpu at the marker bands section, and another kink was observed on the green section of the introducer near the tip introducer.Also, it can be observed that the embolic coil is no longer attached to the rest of the device, although due to the resolution and the distance of the photo it is not possible to determine if the coil has some damage on it or if the rh is heated, the detached condition noted on the embolic coil is related to the customer complaint.A manufacturing record evaluation was performed for the finished device, and no non-conformances related to the reported complaint condition were identified.The device was returned to cerenovus for further investigation.A non-sterile galaxy g3 mini 1mm x 1cm was received contained in the decontamination pouch.Upon receiving the device, a visual inspection was performed, and the core wire was found kinked at 3 inches (7.62 cm) and 14.25 inches (36.195 cm) from the proximal end, this damage is consistent with the damage noted in the picture provided by the customer.No other damages were found in the device.Further inspection under microscopic magnification revealed that the embolic coil was severely stretched, and it remains attached to the rest of the device, as opposed to the event description, and as observed on the photo.The distal outer sheath had not been softened indicating that the resistance heating coil had not been heated and the detachment process was not initiated.Although the coil detachment had been previously confirmed based on the photo received, the returned device confirmed that the embolic coil was still attached and had to be confirmed through observation under magnification.The customer complaint was not confirmed.Coil stretching is a known potential problem associated with the use of this device.The instructions for use (ifu) provide proper handling instructions for the device to prevent this problem from occurring.Stretching can occur during handling where force may have been inadvertently applied plus other procedural factors not described in this complaint can result in stretching of the coil.The stretched condition of the embolic coil was not originally reported in the complaint.With the limited information available, the root cause of the coil stretching remains unknown.It is possible that continuous flush had not been done, without an adequate flush, issue such as resistance between the coil and the microcatheter can arise, which may cause some force to be inadvertently exerted on the device, which can result in the coil becoming stretched or kinked or both.However, this cannot be conclusively determined.There 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 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.Multiple attempts to obtain additional information were unsuccessful.If information is provided at a later date, the file will be reopened and processed accordingly.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.
Additional Manufacturer Narrative
Product complaint#: (b)(4).Section b5: additional information received indicated that the product was stored in a box as in the conventional storage method.The device was stored and handled according to the instructions for use (ifu).There was no damage noted to the packaging.The integrity of the sterile pouch was not compromised.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: GALAXY G3 MINI 1MM X 1CM
• 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: 14654772
• Report Number: 3008114965-2022-00412
• Device Sequence Number: 5109411
• Product Code: KRD
• UDI-Device Identifier: 10886704080213
• UDI-Public: 10886704080213
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/17/2022

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: 04/30/2023
• Device Model Number: GLM910010
• Device Catalogue Number: GLM910010
• Device Lot Number: 30392236
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2022
• Supplement Date Received by Manufacturer: 07/12/2022; 08/01/2022
• Initial Report FDA Received Date: 06/10/2022
• Supplement Report FDA Received Date: 07/28/2022; 08/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2020
• 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
• Patient Sex: Unknown