MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 MINI 1MM X 2.5CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLM910025
Medical Device Problem Codes	Stretched (1601); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Procode: krd/hcg initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not 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.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
Event or Problem Description
As reported by the field, during a coil embolization, a galaxy g3 mini 1mm x 2.5cm coil (glm910025, l13803) was being used as the forth coil.However, the coil couldn't be advanced nor retrieved by the physician.The physician pulled the coil and the unspecified microcatheter (mc) at the same time.After inspection, it turns out to be stretched.The physician used a same like product.The procedure was successfully finished.There was no patient injury reported.No additional information is available.
Additional Manufacturer Narrative
Product complaint # (b)(4).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: as reported by the field, during a coil embolization, a galaxy g3 mini 1mm x 2.5cm coil (glm910025, l13803) was being used as the fourth coil.However, the coil couldn't be advanced nor retrieved by the physician.The physician pulled the coil and the unspecified microcatheter (mc) at the same time.After inspection, it turns out to be stretched.The physician used a same like product.The procedure was successfully finished.There was no patient injury reported.No additional information is available.A non-sterile unit galaxy g3 mini 1mm x 2.5cm was received inside of a pouch.The device was visually inspected, and it was found in good normal conditions, no damages or anomalies were observed on the device during the visual analysis.The galaxy g3 mini 1mm x 2.5cm was inspected under microscope and the embolic coil was found in good normal conditions.A lab sample microcatheter was flushed using a lab sample syringe and after that, the received galaxy g3 mini 1mm x 2.5cm was introduced into the lab sample microcatheter and it was advance inside it, no resistance/friction was felt during the advancement.A manufacturing record evaluation (mre) was performed for the finished device l13803 number, and no non-conformances related to the reported complaint condition were identified.Cerenovus conducted a visual, microscopic inspection and functional test.During the visual analysis of the device, the device was found in good conditions, no damages or anomalies were observed during the visual inspection.During the microscopic inspection the embolic coil was observed in good normal conditions, since no damages were observed on the coil, the customer complaint regarding ¿coil - unraveled/stretched-in microcatheter¿ was not confirmed.A lab sample microcatheter was flushed using a lab sample syringe and after that, the received galaxy g3 mini 1mm x 2.5cm was introduced into the lab sample microcatheter and it was advance inside it, no resistance/friction was felt during the advancement.The customer complaint regarding ¿detachable coil delivery system (dcs) - impeded in microcatheter with no loss of cerebral target position¿ was not confirmed.A manufacturing record evaluation was performed, and no non-conformances related to the reported complaint condition were identified.Impeded in microcatheter and unraveled/stretched-in microcatheter are known potential issues associated with the use of the device.Although no issues were found on the device.The instructions for use (ifu) do contain 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.After flushing, reinsert the introducer into the infusion catheter hub as described in ¿microcoil placement¿ section above.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.If the microcoil is positioned at a relative sharp angle to the microcatheter, a microcoil may stretch or break as it is being withdrawn.By repositioning the distal tip of the microcatheter at or slightly inside the ostium (neck) of the aneurysm, the microcoil may be more easily funneled back into the microcatheter.Pulling the exposed microcoil through the rhv grommet may damage the coil.Assignment of root cause for the events remains speculative and inconclusive, based on the limited information provided and the evidence presented by the returned device; however, it is possible that clinical and procedural factors, including device manipulation and device interaction, may have contributed to the reported failures.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.Since there was no evidence to suggest the events were related to a manufacturing or design issue, no corrective actions will be taken at this time.

• Brand Name: GALAXY G3 MINI 1MM X 2.5CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• MDR Report Key: 12505453
• Report Number: 3008114965-2021-00465
• Device Sequence Number: 5174341
• Product Code: KRD
• UDI-Device Identifier: 10886704080220
• UDI-Public: 10886704080220
• Combination Product (Y/N): N
• PMA/510(K) Number: K171862
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2021

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: 08/31/2021
• Device Model Number: GLM910025
• Device Catalogue Number: GLM910025
• Device Lot Number: L13803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2021
• Supplement Date Received by Manufacturer: 10/11/2021
• Initial Report FDA Received Date: 09/21/2021
• Supplement Report FDA Received Date: 10/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED MICROCATHETER; UNSPECIFIED MICROCATHETER