MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 XSFT HEL 2MM X 8CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number GLX120208

Device Problem Failure to Advance (2524)

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

Event Date 07/27/2023

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.Section d.2b: procode is krd/hcg.Section e.1: the initial reporter phone: +(b)(6).The initial reporter email address was not available / reported.The complaint device was returned for evaluation and analysis.The investigation finding is documented below.Investigation summary: a non-sterile 2mm x 8cm galaxy g3 xsft helical coil was received contained in the decontamination pouch.Visual inspection was performed.It was observed that the embolic coil was returned outside of the introducer.Microscopic inspection was performed.Under magnification, the embolic coil was observed in severely stretched condition.As a result of the stretching, the internal blue fiber was exposed.The coil remains still attached to the resistance heating (rh) coil, which was noted as not softened.No other damages were observed on the device.The issue documented a coil that could not pass through the microcatheter was confirmed based on the appearance of the returned device.The stretched damage observed in the coil was not originally documented in the complaint, however, it could be the result of the impeded condition experienced during the procedure that could not be replicated in the laboratory.Stretching can occur during procedure handling where force may have been inadvertently applied.According to the risk documentation, friction and difficulty to advance are potential issues that can occur during microcoil placement due to continuous saline flush not being established, which can result in coil stretching.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 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 (30742441) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.As part of cerenovus 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) contains the following precautions: ¿ if unusual friction is noticed during advancement or retraction of the microcoil system through the introducer, open the rhv main valve, and partially withdraw the distal end of the introducer to expose its tip within the rhv.Tighten the rhv main valve and flush the y-connector of the rhv with sterile saline and verify that fluid exits the slit in the clear portion of the introducer.¿ 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.Replace it with a new microcoil system.If friction still exists, withdraw, and examine the delivery catheter system.¿ if repositioning of the microcoil is necessary, carefully observe the motion of the microcoil in respect to the dpu wire while retracting the microcoil under fluoroscopy.If the microcoil movement is not one-to-one with the dpu wire, or if repositioning is difficult, the microcoil may have become stretched and could possibly break.Gently remove and discard the microcoil system.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.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 Description

The healthcare professional reported that during an endovascular embolization procedure, the 2mm x 8cm galaxy g3 xsft helical coil (glx120208 / 30742441) was impeded in the microcatheter and could not pass through.The physician retracted the coil and switched to a new coil to complete the procedure using the original microcatheter (unspecified brand).There was no report of any negative patient impact.It was reported that additional information is not available.The complaint device was returned for evaluation and analysis.Based on the product analysis completed on 08-mar-2024, the reported issue meets usfda reporting criteria under 21 cfr 803 as a "malfunction.".

• Brand Name: GALAXY G3 XSFT HEL 2MM X 8CM
• 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): CERENOVUS INC. (FREMONT); 47709 fremont blvd; fremont CA 94538
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-689
• MDR Report Key: 18870719
• MDR Text Key: 337690674
• Report Number: 3008114965-2024-00297
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 10886704077763
• UDI-Public: 10886704077763
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: GLX120208
• Device Lot Number: 30742441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2022
• 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
• Treatment: MICROCATHETER (UNSPECIFIED BRAND)