MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 3MM X 8CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLY120308
Medical Device Problem Codes	Positioning Failure (1158); Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2021
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 was discarded; therefore, no product investigation can be performed.A manufacturing record evaluation (mre) was performed for the finished device l12341 number, and no non-conformances related to the reported complaint condition were identified.The company is seeking this information through the event investigation.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 to a major aortopulmonary collateral artery (mapca), an approach was made from the right femoral artery with a sheath (4f).An angio catheter was advanced toward the left internal thoracic artery.An unspecified concomitant microcatheter (mc) was inserted into the patient and advanced toward a shunt.Coil embolization started.After several galaxy g3 coils were implanted, the complaint product, a 3mm x 8cm galaxy g3 (gly120308, l12341) was opened for additional embolization.But the complaint product came out from the lesion a little, therefore, the position of the microcatheter was changed.The physician attempted to re-sheath.However, it was not able to be re-sheathed.The complaint product was replaced with another one (same catalog number).The procedure was completed safely.
Additional Manufacturer Narrative
Product complaint # : (b)(4).Updated sections on this medwatch report: b5, e1, e2, e3, g3, g6, h3, h6, h2 and h10.Section b5: additional information received indicated that no excessive force was applied to the device.Section e1.Initial reporter phone: (b)(6).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 to a major aortopulmonary collateral artery (mapca), an approach was made from the right femoral artery with a sheath (4f).An angio catheter was advanced toward the left internal thoracic artery.An unspecified concomitant microcatheter (mc) was inserted into the patient and advanced toward a shunt.Coil embolization started.After several galaxy g3 coils were implanted, the complaint product, a 3mm x 8cm galaxy g3 (gly120308, l12341) was opened for additional embolization.But the complaint product came out from the lesion a little, therefore, the position of the microcatheter was changed.The physician attempted to re-sheath.However, it was not able to be re-sheathed.The complaint product was replaced with another one (same catalog number).The procedure was completed safely.Additional information received indicated that no excessive force was applied to the device.The device was discarded; therefore, no product investigation can be performed.A manufacturing record evaluation (mre) was performed for the finished device l12341 number, and no non-conformances related to the reported complaint condition were identified.With the information available and without the product available for analysis, the reported customer complaint of ¿coil - positioning difficulty-coil herniation¿ and ¿coil introducer - zipping difficulty-rezipping¿ could not be confirmed.Based on the mre, there is no indication that the event is related to the device manufacturing process.The instructions for use (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¿.The ifu also instructs the user to unsheathe a small length of the dpu to unlock the device, then to advance the embolic coil into the microcatheter until the hub connector of the dpu reaches the proximal end of the resheathing tool.This results in the placement of the embolic coil and the more flexible and fragile distal sections of the dpu inside the microcatheter before continuing to unsheathe the device.If the device is unsheathed before advancing into the microcatheter, there is a risk that the embolic coil or the distal end of the dpu will be unsheathed and pass through the resheathing tool.If the resheathing tool passes over the distal end of the dpu, this will expose these flexible sections, which will then be subject to kinking and bending.Once a part of the dpu is kinked or bent, the translucent introducer sheath will not be able to re-form around it, and that section of the device will protrude.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint devices; 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.

• Brand Name: GALAXY G3 3MM X 8CM
• 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: 11435559
• Report Number: 3008114965-2021-00109
• Device Sequence Number: 14333451
• Product Code: KRD
• UDI-Device Identifier: 10886704077466
• UDI-Public: 10886704077466
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2021

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: 03/31/2021
• Device Model Number: GLY120308
• Device Catalogue Number: GLY120308
• Device Lot Number: L12341
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2021
• Supplement Date Received by Manufacturer: 03/25/2021
• Initial Report FDA Received Date: 03/08/2021
• Supplement Report FDA Received Date: 04/12/2021
• 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