MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 4MM X 12CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLY120412
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, ethnicity, and medical history were not provided.Procode is krd/hcg.The initial reporter phone: (b)(6).The initial reporter email address was not provided / reported.Conclusion: the healthcare professional reported that during a post-operative type ii endoleak coil embolization post stent-graft implantation, the coil embolization started at the peripheral blood vessel of the superior gluteal artery and the inferior gluteal artery, the physician inserted a concomitant microcatheter for coiling support from the outer cylinder of the puncture needle with a direct puncture from the buttocks, the 4mm x 12cm galaxy g3 coil (gly120412 / l16577) was used as the fourth coil, but it became unraveled when it was advanced toward the target lesion.The complaint coil was removed and replaced with another 4mm x 12cm galaxy g3 coil (gly120412) and the procedure was resumed to completion.There was no report of any blood flow restriction or reduction as a result of the reported event.The physician commented that the complaint coil may have been caught in a wall thrombus inside the target aneurysm.Due to infectious disease, the complaint device is not available for return.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 (l16577) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformances 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.Coil unraveling / stretching is a known potential issue associated with the use of this device.The ifu provides proper handling instructions for the device to prevent such issue from occurring.The embolic coil can become unraveled during attempts to withdraw the coil against resistance.Without the product available to be returned for evaluation and analysis, the possible contributing factors to the reported issue of the coil becoming unraveled as reported in the complaint cannot be conclusively determined.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.In addition, devices undergo 100% inspection at final assembly for the condition of the embolic coil.Thus, it is not likely that the condition of the 4mm x 12cm galaxy g3 coil as reported in the complaint would allow it to leave the manufacturing facility.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.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 post-operative type ii endoleak coil embolization post stent-graft implantation, the coil embolization started at the peripheral blood vessel of the superior gluteal artery and the inferior gluteal artery, the physician inserted a concomitant microcatheter for coiling support from the outer cylinder of the puncture needle with a direct puncture from the buttocks, the 4mm x 12cm galaxy g3 coil (gly120412 / l16577) was used as the fourth coil, but it became unraveled when it was advanced toward the target lesion.The complaint coil was removed and replaced with another 4mm x 12cm galaxy g3 coil (gly120412) and the procedure was resumed to completion.There was no report of any blood flow restriction or reduction as a result of the reported event.The physician commented that the complaint coil may have been caught in a wall thrombus inside the target aneurysm.Due to infectious disease, the complaint device is not available for return.There was no report of any patient adverse event or complication.

• Brand Name: GALAXY G3 4MM X 12CM
• 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: 10629828
• Report Number: 3008114965-2020-00431
• Device Sequence Number: 2605055
• Product Code: KRD
• UDI-Device Identifier: 10886704077480
• UDI-Public: 10886704077480
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/18/2020

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: 07/31/2022
• Device Model Number: GLY120412
• Device Catalogue Number: GLY120412
• Device Lot Number: L16577
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/18/2020
• Initial Report FDA Received Date: 10/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1