MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	GLX120308
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.(b)(4).The purpose of this mdr submission is to report the investigational finding of the returned device.The complaint product was returned and received for evaluation and analysis.The investigation is documented below.Investigation summary: a non-sterile 3mm x 8cm galaxy g3 xsft was received contained in the decontamination pouch.Visual inspection was performed.As noted in the photo that was included with the complaint, the core wire is kinked in a 90-degree angle.Microscopic inspection was performed.Under magnification, the embolic coil was observed to be severely stretched and still attached to the resistance heating (rh) coil.The issue documented in the complaint that the core wire was kinked during the re-sheathing was confirmed based on the appearance of the returned device.It is possible that excessive manipulation may have resulted in core wire kinking.With the limited information available, the root cause cannot be determined.There is no evidence to suggest that the issue reported is a result of a defect inherently related to the device.The coil stretching was not originally documented in the complaint, and its exact time of occurrence cannot be determined since no further information was gathered from the customer.It is possible that the coil became kinked during the unit withdrawal due to rotating hemostasis valve (rhv) overtightening or during the post-operative handling of the device.This condition is not considered related to the issue as reported.A review of manufacturing documentation associated with this lot (30860247) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no internal actions related to device manufacture or inspection.As part of johnson & johnson medtech quality process, all devices are manufactured, inspected, and released to approved specifications.It should be noted that product failure is multifactorial.The instructions for use (ifu) contains the following caution: - 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.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.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.Updated sections.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
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, sex, gender, weight, race, and ethnicity were not provided.Section d.2b: procode is krd/hcg.Section e.1: the initial reporter phone is not available / reported.Section h.3: the device is available to be returned for evaluation and testing.However, it has not been received to date.If the device returns, a device investigation will be performed.The product analysis team reviewed the photo included in the complaint.The review is documented below.[photo review]: the photo included in the complaint shows the core wire tangled with the introducer and a severely stretched coil.A 90-degree kink can be observed the core wire next to the detachment connector.A review of manufacturing documentation associated with this lot (30860247) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no internal actions related to device manufacture or inspection.The issue reported regarding the coil wire being kinked is confirmed based on the core wire kinked condition observed.The stretched condition of the coil was not originally reported; therefore, it is not considered related to the failure reported.This investigation was performed based only on the photo provided.An assessment will be performed as per the conditions of the device returned.As part of j&j medtech quality process all devices are manufactured, inspected, and released to approved specifications.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 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
The healthcare professional reported that during an endovascular embolization procedure, the core wire coil on the 3mm x 8cm galaxy g3 xsft (glx120308 / 30860247) was kinked during resheathing.A photo was included in the complaint.There was no report of any negative patient impact.The product analysis team completed the review of the photo on 24-dec-2024.Based on the review of the photo included in the complaint, the event has been deemed usfda reportable under 21 cfr 803 with a classification of ¿malfunction.".
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product analysis lab received the complaint device on 26-feb-2025.A supplemental 3500a report will be submitted once the product investigation has been completed.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.

• Brand Name: GALAXY G3
• 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: 21097881
• Report Number: 3008114965-2024-01262
• Device Sequence Number: 18468427
• Product Code: KRD
• UDI-Device Identifier: 10886704077701
• UDI-Public: (01)10886704077701(11)220712(17)250630(10)30860247
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/13/2025

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: 06/30/2025
• Device Catalogue Number: GLX120308
• Device Lot Number: 30860247
• 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: 12/24/2024
• Supplement Date Received by Manufacturer: 02/26/2025; 03/13/2025
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 02/26/2025; 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2022
• 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