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

Model Number	GLX122525
Medical Device Problem Codes	Stretched (1601); Unraveled Material (1664)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/10/2020
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 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 number is 3008114965-2020-00493.
Event or Problem Description
As reported by the field, during a coil embolization, of the internal carotid-posterior communicating artery (icpc).Coil embolization started with a neuroform atlas stent, stryker by performing jail technique.A 4mm x 8cm g3 xsft coil was used as the first coil.A 2.5mm x 2.5cm galaxy g3 xsft (glx122525, l13191) was used as a second coil, but there was an intensive resistance felt with a sl10 microcatheter, stryker.The complaint coil was removed, and the physician confirmed that the complaint coil got unraveled.A 2.5mm x 2.5cm galaxy g3 xsft (glx122525, l13190) was used as the third coil, but the same issue occurred again.They were replaced with another two competitive products, and the procedure was completed.
Additional Manufacturer Narrative
Product complaint # (b)(4).Section b5: additional information received indicated that the mc was not damaged during manipulation of the coil or noticed to be damaged upon removal from the patient.The continuous flush on the microcatheter was maintained.There was no excessive force applied to the device.There was no significant procedure prolongation due to the event.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, of the internal carotid-posterior communicating artery (icpc).Coil embolization started with a neuroform atlas stent, stryker by performing jail technique.A 4mm x 8cm g3 xsft coil was used as the first coil.A 2.5mm x 2.5cm galaxy g3 xsft (glx122525, l13191) was used as a second coil but there was an intensive resistance felt with a sl10 microcatheter, stryker.The complaint coil was removed, and the physician confirmed that the complaint coil got unraveled.A 2.5mm x 2.5cm galaxy g3 xsft (glx122525, l13190) was used as the third coil but the same issue occurred again.They were replaced with another two competitive products and the procedure was completed.Additional information received indicated that the mc was not damaged during manipulation of the coil or noticed to be damaged upon removal from the patient.Continuous flush on the microcatheter was maintained.There was no excessive force applied to the device.There was no significant procedure prolongation due to the event.The device was discarded; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device l13190 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 complaints of ¿detachable coil delivery system (dcs) - resistance/friction-during advancement with no loss of cerebral target position¿ and ¿coil - unraveled/stretched-in microcatheter¿ could not be confirmed.Based on the device history record review, 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 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 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).The manufacturing record evaluation (mre) completed on 10/27/2020 for the device involved was inadvertently omitted from the initial mdr.The device was discarded; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device l13191 number, and no non-conformances related to the reported complaint condition were identified.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: GALAXY G3 XSFT 2.5MM 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: 10778468
• Report Number: 3008114965-2020-00494
• Device Sequence Number: 19666589
• Product Code: KRD
• UDI-Device Identifier: 10886704077602
• UDI-Public: 10886704077602
• 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,Followup
• Report Date (Section B): 10/12/2020

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: 06/30/2021
• Device Model Number: GLX122525
• Device Catalogue Number: GLX122525
• Device Lot Number: L13190
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/12/2020
• Supplement Date Received by Manufacturer: 10/27/2020; 12/20/2020
• Initial Report FDA Received Date: 11/03/2020
• Supplement Report FDA Received Date: 11/12/2020; 12/21/2020
• 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 XSFT 2.5MM X 2.5CM; NEUROFORM ATLAS, STRYKER STENT; SL10 MICROCATHETER, STRYKER; UNKGALAXYG3