MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 MINI 2.5MM X 4.5CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLM925045
Medical Device Problem Codes	Break (1069); Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the field, during a recanalization at the internal carotid artery aneurysm, a 2mm x 6cm galaxy g3 mini coil (glm920060, l13998) was used but it was re-sheathed because it came out from the aneurysm.It was replaced with another complaint coil, a 2.5mm x 4.5cm galaxy g3 mini coil (glm925045, l13812) but it also came out from the aneurysm.The physician noticed that the concomitant microcatheter was out of position.Therefore, the complaint coil was re-sheathed once to move the microcatheter at the proper position.The position of the microcatheter was modified.The physician tried to use the complaint coils but the sheathes were damaged.They were replaced with other coils and the procedure was completed.
Additional Manufacturer Narrative
Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Procode: krd/hcg.The device was discarded; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device l13812number, and no non-conformances related to the malfunction were identified.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.This is one of two products involved with the complaint and the associated manufacturer report numbers are 3008114965-2021-00437 and 3008114965-2021-00439.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # = >(b)(4).Updated section on this medwatch report: b5, e1, e2, e3, g3, g6, h2 and h10.Section b5: additional information received indicated that the physician thought the position of the microcatheter was improper and the positioning must have been difficult.Neither of the two coils were reported as being damaged while in the aneurysm.The devices were removed from the patient without additional intervention.It was not necessary to remove concomitant devices with the complaint device.The same mc was used successfully with subsequent coils.The event did not prolong the procedure.Section e1 - initial reporter phone: (b)(6).Complaint conclusion: as reported by the field, during a recanalization at the internal carotid artery aneurysm, a 2mm x 6cm galaxy g3 mini coil (glm920060, l13998) was used but it was re-sheathed because it came out from the aneurysm.It was replaced with another complaint coil, a 2.5mm x 4.5cm galaxy g3 mini coil (glm925045, l13812) but it also came out from the aneurysm.The physician noticed that the concomitant microcatheter was out of position.Therefore, the complaint coil was re-sheathed once to move the microcatheter at the proper position.The position of the microcatheter was modified.The physician tried to use the complaint coils but the sheathes were damaged.They were replaced with other coils and the procedure was completed.Additional information received indicated that the physician thought the position of the microcatheter was improper and the positioning must have been difficult.Neither of the two coils were reported as being damaged while in the aneurysm.The devices were removed from the patient without additional intervention.It was not necessary to remove concomitant devices with the complaint device.The same mc was used successfully with subsequent coils.The event did not prolong the procedure.The device was discarded; therefore, no further investigation can be performed.A manufacturing record evaluation (mre) was performed for the finished device l13812number, and no non-conformances related to the malfunction were identified.With the information available and without the product available for analysis, the reported customer complaints of ¿coil ¿ positioning difficulty ¿ coil herniation¿ and coil introducer ¿ damaged¿ could not be confirmed.Based on the manufacturing record evaluation, there is no indication that the events are related to the device manufacturing process.Positioning difficulties is a known potential product failure associated with the use of the device.The instructions for use (ifu) contains several cautions relating to this situation, including instructions for troubleshooting the situation should it be encountered during use.The ifu instructs on proper positioning of the microcoil system.The ifu also warns: ¿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¿.Assignment of root cause for the events remains speculative and inconclusive, based on the limited information provided and without the return of the complaint device; however, it is possible that clinical and procedural factors, including device manipulation / interaction, aneurysm size and vessel characteristics, device selection, and the concomitant microcatheter, may have contributed to the reported issue.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: GALAXY G3 MINI 2.5MM X 4.5CM
• 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: 12406235
• Report Number: 3008114965-2021-00439
• Device Sequence Number: 14498431
• Product Code: KRD
• UDI-Device Identifier: 10886704080275
• UDI-Public: 10886704080275
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2021

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: GLM925045
• Device Catalogue Number: GLM925045
• Device Lot Number: L13812
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2021
• Supplement Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 09/01/2021
• Supplement Report FDA Received Date: 09/29/2021
• 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: GALAXY G3 MINI 2MM X 6CM; UNSPECIFIED MICROCATHETER