MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 XSFT 3MM X 4CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLX120304
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).The purpose of this mdr submission is to report the findings of the device investigation.The embolic coil was noted as being damaged, meeting regulatory reporting criteria.Procode: krd/hcg.(b)(6).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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Complaint conclusion: as reported by the field, during an emergent an procedure, a 3mm x 4cm galaxy g3 xsft coil was used after an unspecified concomitant microcatheter (mc) was used.However, there was resistance felt during the advancement of the coil and the microcatheter.It was replaced with another coil and the procedure was completed.Additional information received indicated that a continuous flush on the microcatheter was maintained.No excessive force was applied to the device.No additional information is available.Based on the analysis of the device received, the embolic coil is damaged.A non-sterile unit galaxy g3 xsft 3mm x 4cm was received at cerenovus inside of a pouch for evaluation.The device was visually inspected, and it was noted that the dpu is protruded from introducer without damages.No other damages or anomalies were observed on the device during the visual analysis.The device was inspected under a microscope and it was found that the embolic coil has a damage condition.The functional test could not be performed since the dpu was noted protruded from introducer.A manufacturing record evaluation was performed for the finished device l16447 number, and no non-conformances related to the reported complaint condition were identified.Cerenovus conducted a visual and microscopic inspection.The functional test of the device could not be performed due to the conditions in which the device was returned for evaluation.During the visual analysis of the galaxy g3 xsft 3mm x 4cm, it was noted that the dpu is protruded from introducer without damages, the protruded condition is related with the customer complaint regarding ¿detachable coil delivery system (dcs) - resistance/friction-during advancement with no loss of cerebral target position¿.Based on the findings during the analysis, the customer complaint was confirmed.During the microscopic inspection it was observed the embolic coil is damaged.A manufacturing record evaluation was performed, and no non-conformances related to the reported complaint condition were identified.Assignment of root cause for the event 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 failure and damages on the returned system.It should be noted that product failure is multifactorial.The instructions for use do contain the following cautions: never advance, withdraw, or torque the delivery tube against resistance without first determining the cause of resistance under fluoroscopy.Manipulation of the delivery tube against resistance can cause damage and/or premature detachment of the coil.If unusual friction is noted within the infusion catheter, remove the detachable coil system.Refer to coil retrieval.If friction is noted with any subsequent detachable coil system, carefully examine the detachable coil system and the infusion catheter for possible damage.Replace both if necessary.Refer to coil retrieval.The detachable coils are delicate and must be handled carefully.Prior to use and when possible during the procedure, inspect the system for bends or kinks.Do not use a coil system showing signs of damage.Failure to open the second rhv sufficiently prior to slow and careful removal of the delivery tube from the patient could result in damage to the distal portion of the delivery tube.As part of 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 event was related to a manufacturing or design issue, no corrective actions will be taken at this time.
Event or Problem Description
As reported by the field, during an emergent an procedure, a 3mm x 4cm galaxy g3 xsft coil was used after an unspecified concomitant microcatheter (mc) was used.However, there was resistance felt during advancement of the coil and the microcatheter.It was replaced with another coil and the procedure was completed.Additional information received indicated that continuous flush on the microcatheter was maintained.No excessive force was applied to the device.No additional information is available.Based on the analysis of the device received, the embolic coil is damaged.

• Brand Name: GALAXY G3 XSFT 3MM X 4CM
• 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: 12259300
• Report Number: 3008114965-2021-00365
• Device Sequence Number: 3164354
• Product Code: KRD
• UDI-Device Identifier: 10886704077688
• UDI-Public: 10886704077688
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/11/2021

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: 06/30/2022
• Device Model Number: GLX120304
• Device Catalogue Number: GLX120304
• Device Lot Number: L16447
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2021
• Initial Report FDA Received Date: 08/02/2021
• 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