MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 XSFT 4MM X 10CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLX120410
Medical Device Problem Codes	Break (1069); Difficult to Advance (2920); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.Procode is krd/hcg.The name, phone and email address of the initial reporter are not available / reported.[conclusion]: the healthcare professional reported that during a peripheral arterial occlusion procedure targeting a colonic artery aneurysm, the 4mm x 10cm galaxy g3 xsft coil (glx120410 / 30376373) was the first coil used; it was resheathed because it could not be winded as intended event though it was re-winded several times.The complaint coil was re-inserted but there was a slight resistance felt and part of the sheath became damaged and became difficult to deliver.The coil component was reported as normal without any issue.Another coil of a different size was chosen as a replacement and it was implanted in the target lesion without any issue.The procedure was completed with two electronic coils and eight pushable coils.There was no report of any patient adverse event or complication.Based on complaint information, the device was not available to be returned for analysis.A review of manufacturing documentation associated with this lot (30376373) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.With the limited information available and without the product available for analysis, the reported customer complaint could not be confirmed.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint sample; however, it is possible that clinical and procedural factors, including device manipulation / interaction, aneurysm size / vessel characteristics, device selection, and the concomitant microcatheter, may have contributed to the reported issue.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered at a later time.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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
The healthcare professional reported that during a peripheral arterial occlusion procedure targeting a colonic artery aneurysm, the 4mm x 10cm galaxy g3 xsft coil (glx120410 / 30376373) was the first coil used; it was resheathed because it could not be winded as intended event though it was re-winded several times.The complaint coil was re-inserted but there was a slight resistance felt and part of the sheath became damaged and became difficult to deliver.The coil component was reported as normal without any issue.Another coil of a different size was chosen as a replacement and it was implanted in the target lesion without any issue.The procedure was completed with two electronic coils and eight pushable coils.There was no report of any patient adverse event or complication.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 18 july 2021.E.1: initial reporter phone: (b)(6).[additional information]: the healthcare professional reported that during a peripheral arterial occlusion procedure targeting a colonic artery aneurysm, the 4mm x 10cm galaxy g3 xsft coil (glx120410 / 30376373) was the first coil used; it was resheathed because it could not be winded as intended event though it was re-winded several times.The complaint coil was re-inserted but there was a slight resistance felt and part of the sheath became damaged and became difficult to deliver.The coil component was reported as normal without any issue.Another coil of a different size was chosen as a replacement and it was implanted in the target lesion without any issue.The procedure was completed with two electronic coils and eight pushable coils.There was no report of any patient adverse event or complication.On 18 july 2021, additional information was received.The information indicated that it was not necessary to remove the microcatheter from the target when the resistance was encountered.There was nothing obstructing the microcatheter and no damage when it was removed.A continuous flush was maintained through the microcatheter during the procedure.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

• Brand Name: GALAXY G3 XSFT 4MM X 10CM
• 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: 12178559
• Report Number: 3008114965-2021-00278
• Device Sequence Number: 909651
• Product Code: KRD
• UDI-Device Identifier: 10886704077718
• UDI-Public: 10886704077718
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2021

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: 03/31/2023
• Device Model Number: GLX120410
• Device Catalogue Number: GLX120410
• Device Lot Number: 30376373
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2021
• Supplement Date Received by Manufacturer: 07/18/2021
• Initial Report FDA Received Date: 07/15/2021
• Supplement Report FDA Received Date: 07/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1