MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 XSFT 4MM X 6CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number GLX120406

Device Problem Stretched (1601)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/11/2021

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.Procode is krd/hcg.The initial reporter phone: (b)(6).The initial reporter email address is not available / 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.A review of manufacturing documentation associated with this lot (30399444) 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.All product rejected during manufacturing was identified as scrap and properly accounted for.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional information will be submitted within 30 days of receipt.

Event Description

The healthcare professional reported that during a coil embolization of an unruptured internal carotid-posterior communicating aneurysm, the 4mm x 6cm galaxy g3 xsft coil (glx120406 / 30399444) was used as a framing coil.It was resheathed because the size did not fit the target lesion.However, it was reported that there was a possibility that the coil was unraveled.To avoid risk, the complaint coil was replaced with another coil and the procedure was successfully completed.Continuous flush was maintained through the microcatheter.There was no report of any patient injury or complication.On 25-nov-2021, additional information was received.The information confirmed that the procedure date was (b)(6)2021.The size of the coil did not fit the lesion.There was no additional damage noted on the coil when it was removed.The reported event did not result in any blood flow restriction / reduction.The event did not result in any clinically significant delay in the procedure.

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 04-jan-2022.A supplemental 3500a report will be submitted once the product investigation has been completed.Updated sections: b.4, d.9, g.3, g.6.H.2, h.3, h.6, and h.10.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.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigational finding of the returned device.[conclusion]: the healthcare professional reported that during a coil embolization of an unruptured internal carotid-posterior communicating aneurysm, the 4mm x 6cm galaxy g3 xsft coil (glx120406 / 30399444) was used as a framing coil.It was resheathed because the size did not fit the target lesion.However, it was reported that there was a possibility that the coil was unraveled.To avoid risk, the complaint coil was replaced with another coil and the procedure was successfully completed.Continuous flush was maintained through the microcatheter.There was no report of any patient injury or complication.On 25-nov-2021, additional information was received.The information confirmed that the procedure date was (b)(6) 2021.The size of the coil did not fit the lesion.There was no additional damage noted on the coil when it was removed.The reported event did not result in any blood flow restriction / reduction.The event did not result in any clinically significant delay in the procedure.The complaint product was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: a non-sterile 4mm x 6cm galaxy g3 xsft coil was received contained in a pouch.Visual inspection was performed.The embolic coil was observed completely unraveled but still attached to the core wire.Microscopic inspection was performed.The core wire was observed slightly bent.Functional test could not be performed due to the condition of the embolic coil.A review of manufacturing documentation associated with this lot (30399444) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.The complaint documented that the 4mm x 6cm galaxy g3 xsft coil was used as a framing coil during a coil embolization procedure of an unruptured internal carotid-posterior communicating artery aneurysm, it was resheathed because the size did not fit the target aneurysm.It was reported that there was a possibility that the coil had unraveled.The complaint device was returned for analysis.Visual inspection noted the embolic coil in a completely unraveled state, still attached to the core wire that was observed to be slightly bent.The condition of the embolic coil precluded functional testing.However, the reported issue in the complaint was confirmed.It should be noticed that failure could be caused by multiple factors.However, the instructions for use (ifu) contains the following precautions: if the microcoil system becomes immobile in the infusion microcatheter, apply a gentle push-pull motion to free it.If unsuccessful, remove both microcatheter and microcoil system together as a unit and replace with new devices.If unusual friction is still noticed during advancement or retraction of the microcoil system, verify flush lines are open and properly pressurized.Then slowly withdraw the entire microcoil system and examine for damage.Coil unraveling / stretching is a known potential issue associated with the use of this device.The instructions for use (ifu) provides proper handling for the device to prevent such issue from occurring.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.In addition, devices undergo 100% inspection at final assembly for the condition of the embolic coil.Thus, it is not likely that the 4mm x 6cm galaxy g3 xsft coil left the manufacturing facility with the embolic coil in an unraveled condition.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 4MM X 6CM
• Type of Device: 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 949789-868
• MDR Report Key: 12930864
• MDR Text Key: 288831628
• Report Number: 3008114965-2021-00579
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 10886704077725
• UDI-Public: 10886704077725
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K150319
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/26/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: GLX120406
• Device Catalogue Number: GLX120406
• Device Lot Number: 30399444
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2021
• Initial Date FDA Received: 12/04/2021
• Supplement Dates Manufacturer Received: 01/04/2022; 01/26/2022
• Supplement Dates FDA Received: 01/04/2022; 01/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1