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

Model Number	GLY120308
Medical Device Problem Codes	Stretched (1601); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2021
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 further investigation can be performed.A manufacturing record evaluation was performed for the finished device 30517627 number, and no non-conformances related to the malfunction were identified.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 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.This is one of two products involved with the complaint and the associated manufacturer report numbers: 3008114965-2021-00332.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
As reported by the field, during a coil embolization at the left gastric artery, a cerenovus coil (product code, lot number unknown) was used as the first coil and coil embolization started.There was a little resistance felt between the coil and a carnelian marvel, tokai medical products microcatheter before the coil comes out the blood vessel.The coil was able to come out from the microcatheter (mc) therefore, it was detached and implanted.A galaxy g3 3mm x 8cm coil (gly120308, 30517627) was used as the second coil and the same issue occurred.It was re-inserted from the microcatheter several times to implant the coil but the complaint became unraveled.It was replaced with another same sized coil and it was implanted.After that, a galaxy g3 4mm x 12cmcoil (gly120412, 30517630) was used as the fourth coil.The same issue occurred; the physician did the same measure as the former complaint coil but the fourth coil became unraveled.It was replaced with another same sized coil and it was implanted.No patient injury was reported.
Additional Manufacturer Narrative
Product complaint # (b)(4).Section b5: additional information was received confirming that the resistance was encountered with all three complaint coils.Other devices were successfully used with the same microcatheter prior to the first complaint coil as well with some of the replaced coils.There was no report of any damage to the mc.There was nothing noted obstructing the microcatheter.A continuous flush on the microcatheter was maintained.The introducer was flushed until the liquid was visible at the distal end of the slit in the clear tube.There was no excessive force 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 at the left gastric artery, a cerenovus coil (product code, lot number unknown) was used as the first coil and coil embolization started.There was a little resistance felt between the coil and a carnelian marvel, tokai medical products microcatheter before the coil comes out the blood vessel.The coil was able to come out from the microcatheter (mc) therefore, it was detached and implanted.A galaxy g3 3mm x 8cm coil (gly120308, 30517627) was used as the second coil and the same issue occurred.It was re-inserted from the microcatheter several times to implant the coil but it became unraveled.It was replaced with another same sized coil and it was implanted.After that, a galaxy g3 4mm x 12cmcoil (gly120412, 30517630) was used as the fourth coil.The same issue occurred; the physician did the same measure like the former complaint coil but the fourth coil became unraveled.It was replaced with another same-sized coil and it was implanted.No patient injury was reported.Additional information was received confirming that the resistance was encountered with all three complaint coils.Other devices were successfully used with the same microcatheter prior to the first complaint coil as well with some of the replaced coils.There was no report of any damage to the mc.There was nothing noted obstructing the microcatheter.A continuous flush on the microcatheter was maintained.The introducer was flushed until the liquid was visible at the distal end of the slit in the clear tube.There was no excessive force applied to the device.The device was discarded; therefore, no further investigation can be performed.A manufacturing record evaluation (mre) was performed for the finished device 30517627 number, and no non-conformances related to the malfunction were identified.With the information available and without the product available for analysis, the reported customer complaint of ¿detachable coil delivery system - resistance/friction during advancement with no loss of cerebral target position¿ and ¿coil ¿ unraveled/stretched¿ could not be confirmed.Based on the manufacturing record evaluation, there is no indication that the events were related to the device manufacturing process.The instructions for use (ifu) caution that if unusual friction is still noticed during advancement or retraction of the coil system, verify flush lines are open and properly pressurized.Then slowly withdraw the entire catheter system and examine for damage.Replace it with a new system.If friction still exists, withdraw and examine the delivery catheter 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, vessel characteristics, device selection, and the concomitant microcatheter, may have contributed to the reported issues.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: 12225656
• Report Number: 3008114965-2021-00331
• Device Sequence Number: 4486790
• 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,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2021

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: 01/31/2024
• Device Model Number: GLY120308
• Device Catalogue Number: GLY120308
• Device Lot Number: 30517627
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2021
• Supplement Date Received by Manufacturer: 08/11/2021
• Initial Report FDA Received Date: 07/26/2021
• Supplement Report FDA Received Date: 08/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1