MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 XSFT 3MM X 8CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	GLX120308
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The healthcare professional reported during an endovascular embolization procedure, the coil sheath of the complaint device, a 3mm x 8cm galaxy g3 xsft (glx120308 / 30820681) was broken during resheathing.There was no report of any negative patient impact.Multiple attempts to obtain additional information related to the procedure and the reported device issue were unsuccessful.If additional information is received at a later date, this file will be updated accordingly.Based on the result of the product analysis completed on 19-sep-2024, the reported issue meets usfda reporting criteria under 21 cfr 803 as a "malfunction.".
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.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.It was observed that the coil was severely stretched and tangled with the rest of the delivery system.The core wire and the introducer were found kinked near the resheathing tool.Microscopic inspection was performed.It was observed that as a result of the stretched coil, the blue fiber snapped.The resistance heating (rh) coil was noted not to be softened; an indication that the detachment process was not initiated.The issue documented that the sheath got broken was confirmed since the damages noted in the introducer component prevented the device from being re-sheathed.With the information available, the root cause of such damages cannot be conclusively determined.According to the risk documentation, friction is a potential failure mode that can occur during microcoil re-sheathing; friction can cause force to be inadvertently applied, resulting in the damages observed, which ultimately led to the inability to re-sheath the coil.There is no indication that the issues reported in the complaint result from a defect inherently related to the enterprise device.The stretched condition of the coil was not originally reported in the complaint and the exact time when this condition occur cannot be determined.Coil stretching is a known potential issue associated with the use of this device; stretching can occur during procedure handling where force may have been inadvertently applied.The instructions for use (ifu) provide proper handling instructions for the device to prevent such issues from occurring.There is no indication that the issue reported is a result of a defect inherently related to the device.A review of manufacturing documentation associated with this lot (30820681) 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.As part of johnson & johnson medtech quality process, all devices are manufactured, inspected, and released to approved specifications.It should be noted that multiple factors could cause product failure.The instructions for use (ifu) does contain the following recommendation: 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.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 XSFT 3MM X 8CM
• 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: 20260892
• Report Number: 3008114965-2024-00932
• Device Sequence Number: 20884836
• Product Code: KRD
• UDI-Device Identifier: 10886704077701
• UDI-Public: (01)10886704077701(11)220614(17)250531(10)30820681
• 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
• Report Date (Section B): 09/19/2024

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: 05/31/2025
• Device Catalogue Number: GLX120308
• Device Lot Number: 30820681
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2022
• 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