MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 XSFT 3.5MM X 5CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLX123505
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the field, during a coil embolization to the right internal carotid artery of a total choroidal artery aneurysm, a shoryu hr balloon catheter was held distal of the aneurysm for rescue in the event of vascular perforation.A galaxy g3 xsft 3.5mm x 5cm coil (glx123505, 30517624) was inserted as the second coil.The coil was wounded outside the frame.The complaint coil was re-sheathed because the physician thought the size did not fit.However, the coil detachment part was unraveled.There was no negative impact on the patient.It is unknown if a continuous flush was done.Other concomitant devices are a guidewire (synchro select 0.014" 215cm), a guiding catheter (fubuki hard 7fr 90cm), and a microcatheter (exselsior sl10).Additional information received indicated that is is unknown if the coil prematurely detached.There was no excessive force used at any time with the device.No resistance was reported.
Additional Manufacturer Narrative
Product complaint # (b)(4).Procode: krd/hcg.Initial reporter phone: (b)(6).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.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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Complaint conclusion: as reported by the field, during a coil embolization to the right internal carotid artery of a total choroidal artery aneurysm, a shoryu hr balloon catheter was held distal of the aneurysm for rescue in the event of vascular perforation.A galaxy g3 xsft 3.5mm x 5cm coil (glx123505, 30517624) was inserted as the second coil.The coil was wounded outside the frame.The complaint coil was re-sheathed because the physician thought the size did not fit.However, the coil detachment part was unraveled.There was no negative impact on the patient.It is unknown if a continuous flush was done.Other concomitant devices are a guidewire (synchro select 0.014" 215cm), a guiding catheter (fubuki hard 7fr 90cm), and a microcatheter (exselsior sl10).Additional information received indicated that it is unknown if the coil prematurely detached.There was no excessive force used at any time with the device.No resistance was reported.A non-sterile galaxy g3 xsft 3.5mm x 5cm was received contained in the decontamination pouch.Upon receiving the device, a visual inspection was performed, and a portion of the embolic coil was found stretched and outside the introducer sheath.The introducer sheath and hypo-tube were observed to be in good normal condition (i.E., no kinks, bents, compresses).A microscopical inspection was performed, and the embolic coil was found severely stretched; it was noted that because of the stretching found, the blue fiber was exposed.The distal outer sheath was not softened, indicating that the resistance heating (rh) had not been heated and the detachment process was not initiated.The issue documented in the complaint that the coil became stretched was confirmed.Coil stretching is a known potential issue associated with the use of this device.The instructions for use (ifu) provide proper handling instructions for the device to prevent such issue from occurring.It should be noted that it is unknown if a continuous flush was done; without a continuous flush, issues such as resistance with the coil and the microcatheter may arise.According to the risk documentation, friction is a potential failure mode that can occur during microcoil re-sheathing due to rhv not adequately loosened, introducer sheath too tight within rhv, and resheating technique; friction can cause force to be inadvertently applied, resulting in coil stretching.The coil stretching was not observed during the initial inspection nor coil positioning.As such, 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-conformance was found during the review.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) do contain the following caution: pulling the exposed microcoil through the rhv grommet may damage the coil.As part of cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.Devices undergo 100% inspection at different points along the manufacturing process to prevent damages such as coil stretching from leaving the facility.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no capa activity is required.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 3.5MM X 5CM
• 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: 16246811
• Report Number: 3008114965-2023-00073
• Device Sequence Number: 20409766
• Product Code: KRD
• UDI-Device Identifier: 10886704077657
• UDI-Public: 10886704077657
• 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,Followup
• Report Date (Section B): 03/08/2023

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: 01/31/2024
• Device Model Number: GLX123505
• Device Catalogue Number: GLX123505
• Device Lot Number: 30517624
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2023
• Supplement Date Received by Manufacturer: 02/17/2023
• Initial Report FDA Received Date: 01/26/2023
• Supplement Report FDA Received Date: 03/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: EXSELSIOR SL10 MICROCATHETER.; FUBUKI HARD 7FR 90CM GUIDE CATHETER.; SHORYU HR BALLOON CATHETER.; SYNCHRO SELECT 0.014" 215CM GUIDEWIRE.
• Patient Sex: Unknown