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

Model Number	GLX120202
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).The customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.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.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.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
Event or Problem Description
As reported by the field, during a coil embolization, a galaxy g3 xsft 2mm x 2cm coil (glx120202, 30546466) was used as the third coil.When the physician tried to detach the coil, the beeping sound was normal but during retrieving the delivery system, it continuously came out along the delivery system.The physician decided to pull it out and used a same like product.The procedure was successfully finished.There was no patient injury reported.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that multiple attempts to obtain additional information related to the procedure, the reported device issue, and to obtain the product for analysis were unsuccessful.If additional information is available at a later date and the product is returned, the file will be updated accordingly.The device has not been returned for analysis and therefore, no further investigation can be performed at this time.As a result, we are closing this investigation.If the complaint device is received in the future, we will reopen the complaint and perform the investigation as appropriate.A review of manufacturing documentation associated with this lot (30546466) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.With the information available and without the complaint product available to be returned for analysis, the reported issue in the complaint cannot be confirmed.Based on the manufacturing documentation review, 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 may have contributed to the reported failure.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.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
Product complaint # (b)(4).The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
Additional Manufacturer Narrative
Product complaint # = > (b)(4).Updated sections on this medwatch: b4, g3, g6, h2, h3, h6 and h10.A non-sterile galaxy g3 xsft 2mm x 2cm coil was received contained in the decontamination pouch.Upon receiving the device, visual inspection was performed, and it was noted that the embolic coil was not attached to the delivery system.One (1) curvature condition was noted at 14.5 cm.Four (4) kinked conditions were found; the first right next to the connector of the delivery system, the second at 32.9 cm, the third at 106.5 cm, and the fourth at 114.6 cm.All measurements were taken from the proximal end of the device.A slit was noted on the introducer causing the corewire to protrude.Microscopic inspection was performed, and the distal outer sheath was softened, indicating that the resistance heating (rh) coil had been heated and the detachment process was initiated.A manufacturing record evaluation was performed, and no non-conformances related to the reported complaint condition were identified.The issue reported regarding a failure to detach was not confirmed since the resistance heating (rh) was heated and the coil was detached from the unit.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.The curvature and kinked conditions of the corewire, and the slit on the introducer were not originally reported, the exact time of this occurrence cannot be determined, and they are not related to the issue encountered during the procedure.As part of cerenovus quality process all devices are manufactured, inspected, and released to approved specifications.Since no issues were identified, no capa activity is required.The instructions for use (ifu) do contain the following caution: ¿ always perform fluoroscopic verification of detachment prior to withdrawing the dpu wire fully.Failure to do so may lead to an embolic complication.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: GALAXY G3 XSFT 2MM X 2CM
• 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: 16371246
• Report Number: 3008114965-2023-00107
• Device Sequence Number: 6927019
• Product Code: KRD
• UDI-Device Identifier: 10886704077640
• UDI-Public: 10886704077640
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/12/2023

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: 03/31/2024
• Device Model Number: GLX120202
• Device Catalogue Number: GLX120202
• Device Lot Number: 30546466
• 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: 01/27/2022
• Supplement Date Received by Manufacturer: 04/26/2023; 09/05/2023; 10/10/2023
• Initial Report FDA Received Date: 02/14/2023
• Supplement Report FDA Received Date: 04/26/2023; 09/26/2023; 10/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2021
• 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
• Patient Sex: Unknown