MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 XSFT 4MM X 6CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLX120406
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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.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.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 of an aneurysm for type ii endoleake after a stent-graft implantation, coiling embolization started at the peripheral blood vessel of the superior gluteal artery and the inferior gluteal artery.A 4mm x 6cm galaxy g3 xsft coil (glx120406, l10867) became unraveled when it was advancing in the lesion.The unraveled coil was removed from the patient and replaced with another same sized coil (glx120406).The procedure continued.
Additional Manufacturer Narrative
Product complaint # (b)(4).Section b5: additional information received indicated that there was no patient injury.The coil was inspected prior to use.There had been no blood flow restriction/reduction as a result of the event.Excessive force was not used at any time of the handling of 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 of an aneurysm for type ii endoleake after a stent-graft implantation, coiling embolization started at the peripheral blood vessel of the superior gluteal artery and the inferior gluteal artery.A 4mm x 6cm galaxy g3 xsft coil (glx120406, l10867) became unraveled when it was advancing in the lesion.The unraveled coil was removed from the patient and replaced with another same sized coil (glx120406).The procedure continued.Additional information received indicated that there was no patient injury.The coil was inspected prior to use.There had been no blood flow restriction/reduction as a result of the event.Excessive force was not used at any time of the handling of the device.The device was discarded; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device l10867 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 - unraveled/stretched-during use¿ could not be confirmed.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.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 event was 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 02-nov-2020 for the device involved was inadvertently omitted from the initial mdrs.The device was discarded; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device l10867 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 4MM X 6CM
• 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: 10786014
• Report Number: 3008114965-2020-00499
• Device Sequence Number: 17177350
• Product Code: KRD
• UDI-Device Identifier: 10886704077725
• UDI-Public: 10886704077725
• 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): 10/15/2020

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: 11/30/2020
• Device Model Number: GLX120406
• Device Catalogue Number: GLX120406
• Device Lot Number: L10867
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2020
• Supplement Date Received by Manufacturer: 11/02/2020; 12/20/2020
• Initial Report FDA Received Date: 11/04/2020
• Supplement Report FDA Received Date: 11/12/2020; 12/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1