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

Model Number	GLY120308
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2020
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 is not available.The device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation.If the device returns, a device investigation will be performed.A review of manufacturing documentation associated with this lot (30386784) 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.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 the procedure targeting a lesion on the lumbar artery, the 3mm x 8cm galaxy g3 coil (gly120308 / 30386784) was being advanced as usual but it was not able to advance further when it was inserted into the hub of the concomitant 1.9 fr carnelian® marvel® microcatheter (tokai medical).It was reported that a continuous flush had been maintained through the microcatheter.The physician attempted to resheath and the delivery wire was retracted, but the coil was already detached.The introducer sheath was removed carefully to avoid having the coil left inside the hub.The coil left as if it was stuck on the distal end of the sheath.It was replaced with another 3mm x 8cm galaxy g3 coil and the replacement coil advanced without any issue through the same concomitant microcatheter.The procedure was continued without any procedure delay.It was reported that the same microcatheter was used to complete the procedure.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 report that the product was received by cerenovus product analysis lab on 1/15/2021.The returned product underwent evaluation and analysis.[conclusion]: the healthcare professional reported that during the procedure targeting a lesion on the lumbar artery, the 3mm x 8cm galaxy g3 coil (gly120308 / 30386784) was being advanced as usual but it was not able to advance further when it was inserted into the hub of the concomitant 1.9 fr carnelian® marvel® microcatheter (tokai medical).It was reported that a continuous flush had been maintained through the microcatheter.The physician attempted to resheath and the delivery wire was retracted, but the coil was already detached.The introducer sheath was removed carefully to avoid having the coil left inside the hub.The coil left as if it was stuck on the distal end of the sheath.It was replaced with another 3mm x 8cm galaxy g3 coil and the replacement coil advanced without any issue through the same concomitant microcatheter.The procedure was continued without any procedure delay.It was reported that the same microcatheter was used to complete the procedure.There was no report of any patient adverse event or complication.The returned device underwent evaluation and analysis.The investigational finding is documented below.Investigation summary: the non-sterile 3mm x 8cm galaxy g3 coil was received contained in a pouch.Visual inspection was performed.The device positioning unit (dpu) was kinked at 152cm from the proximal end.No other damages or anomalies were observed.The marker band was found at 43cm from the hub; this is within specification.Microscopic inspection was performed.The embolic coil was observed detached and partially inside the introducer in damaged condition.A review of manufacturing documentation associated with this lot (30386784) 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.The complaint reported that during the procedure targeting a lesion on the lumbar artery, the 3mm x 8cm galaxy g3 coil was being advanced as usual but it was not able to be further advanced when it was inserted into the hub of the concomitant microcatheter.The physician attempted to resheath and the delivery wire was retracted, but the coil already became detached; it was stuck on the distal end of the sheath.The reported issue was confirmed.The returned device had the embolic coil detached and stuck inside the introducer as reported in the complaint.Based on the manufacturing documentation 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 3mm x 8cm galaxy g3 coil left the manufacturing facility with the embolic coil in the damaged condition as noted during the microscopic inspection of the returned device.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.Updated sections: d.9, g.3, g.6, h.2, h.3, h.6, and h.10.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 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: 11103114
• Report Number: 3008114965-2020-00605
• Device Sequence Number: 3786285
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2020

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: 03/31/2023
• Device Model Number: GLY120308
• Device Catalogue Number: GLY120308
• Device Lot Number: 30386784
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2020
• Supplement Date Received by Manufacturer: 01/15/2021
• Initial Report FDA Received Date: 12/31/2020
• Supplement Report FDA Received Date: 01/19/2021
• 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: CARNELIAN® MARVEL® MICROCATHETER (TOKAI MEDICAL).