MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 XSFT 3.5MM X 7.5CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	GLX123575
Medical Device Problem Codes	Stretched (1601); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.Section d.2b: procode is krd/hcg.Section e.1: the name, phone and email address of the initial reporter are not available / reported.Based on complaint information, the device is not available to be returned for analysis.A review of manufacturing documentation associated with this lot (30677939) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformance's related to device manufacture or inspection.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.With the information available and without the complaint product available to be returned for analysis, the reported product issue documented in the complaint cannot be confirmed through functional evaluation and analysis.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 device; 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.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2024-00051.This report is being submitted pursuant to the provisions of 21 cfr, part 803.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.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.
Event or Problem Description
On (b)(6) 2024, the healthcare professional initiated the complaint with limited details.It was reported that ¿the procedure details were unknown.The galaxy g3 xsft coils were used and resistance was felt in the microcatheter.Continuous flush was done.The lesion was unknown.Other concomitant device was an excelsior® sl-10® microcatheter (stryker).¿ there was no report of any negative patient impact.On (b)(6) 2024, additional information was received.Per the information, the procedure was a coil embolization of an anterior communicating artery aneurysm.The galaxy g3 xsft coils were used in accordance with the ifu.An excelsior® sl-10® microcatheter (stryker) was placed in the aneurysm.The first framing galaxy g3 coil was introduced without issue, was detached, and implanted.Then the second coil, a 4mm x 8cm galaxy g3 xsft (glx120408 / 30666663) encountered resistance and got stuck inside the microcatheter (not at the proximal side, probably in the middle part of the microcatheter).The physician attempted to withdraw the coil and the coil became unraveled.The microcatheter was replaced with another excelsior® sl-10® microcatheter and the coil was replaced with the third coil, a 3.5mm x 7.5cm galaxy g3 xsft (glx123575 / 30677939); this coil also became stuck inside the microcatheter and during the attempt to withdraw the coil, it became unraveled.The microcatheter was replaced with a headway microcatheter (microvention), the coil was replaced with another coil ¿other than g3¿ (unspecified brand).The procedure was successfully completed.Per the information, ¿both coils (lot 30666663 and lot 30677939) got stuck inside the microcatheter and were not exposed to the patient¿s body.¿ on (b)(6) 2024, additional information was received.The information indicated that the resistance was first felt inside the microcatheter.The first g3 coil could be used without any problems, the second coil encountered resistance in the microcatheter which was replaced; however the third coil also encountered resistance.By replacing the sl-10 microcatheter with a headway microcatheter and replacing the coil with another coil not a g3, the procedure was successfully completed.Continuous flush was maintained in the microcatheter during the procedure.Based on the additional information received on (b)(6) 2024, the reported issue associated with both coils have been deemed reportable as "malfunctions.".

• Brand Name: GALAXY G3 XSFT 3.5MM X 7.5CM
• 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): CERENOVUS INC. (FREMONT); 47709 fremont blvd; fremont CA 94538
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-6892
• MDR Report Key: 18585278
• Report Number: 3008114965-2024-00052
• Device Sequence Number: 8203199
• Product Code: KRD
• UDI-Device Identifier: 10886704077664
• UDI-Public: 10886704077664
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/25/2024

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: 10/31/2024
• Device Catalogue Number: GLX123575
• Device Lot Number: 30677939
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2024
• Initial Report FDA Received Date: 01/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2021
• 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: EXCELSIOR® SL-10® MICROCATHETER (STRYKER); GALAXY G3 XSFT 4MM X 8CM
• Patient Sex: Unknown